PREGABALIN- pregabalin capsule
Zydus Lifesciences Limited

----------

Pregabalin Capsules, CV

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1568-9 in bottle of 90 capsules

Pregabalin capsules, 25 mg

Rx only

90 capsules

NDC 70771-1569-9 in bottle of 90 capsules

Pregabalin capsules, 50 mg

Rx only

90 capsules

NDC 70771-1570-9 in bottle of 90 capsules

Pregabalin capsules, 75 mg

Rx only

90 capsules

NDC 70771-1571-9 in bottle of 90 capsules

Pregabalin capsules, 100 mg

Rx only

90 capsules

NDC 70771-1572-9 in bottle of 90 capsules

Pregabalin capsules, 150 mg

Rx only

90 capsules

NDC 70771-1573-9 in bottle of 90 capsules

Pregabalin capsules, 200 mg

Rx only

90 capsules

NDC 70771-1574-9 in bottle of 90 capsules

Pregabalin capsules, 225 mg

Rx only

90 capsules

NDC 70771-1575-9 in bottle of 90 capsules

Pregabalin capsules, 300 mg

Rx only

90 capsules

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1568
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	25 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (WHITE) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	14mm
Flavor		Imprint Code	865
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1568-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1568-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1568-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1569
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	50 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW (PALE YELLOW) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	15mm
Flavor		Imprint Code	866
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1569-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1569-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1569-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1570
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	75 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK (PEACH) , WHITE (WHITE)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	867
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1570-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1570-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1570-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1571
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	100 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK (PEACH) , PINK (PEACH)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	15mm
Flavor		Imprint Code	868
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1571-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1571-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1571-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1572
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	150 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (IVORY) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	17mm
Flavor		Imprint Code	869
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1572-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1572-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1572-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1573
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	200 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE (LIGHT ORANGE) , ORANGE (LIGHT ORANGE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	870
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1573-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1573-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1573-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1574
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	225 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE (LIGHT ORANGE) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	871
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1574-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1574-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1574-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

PREGABALIN
pregabalin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1575
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	300 mg

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE (ORANGE) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	21mm
Flavor		Imprint Code	872
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1575-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2025	03/25/2025
2	NDC:70771-1575-4	10 in 1 CARTON	02/14/2025	03/25/2025
2	NDC:70771-1575-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206752	02/14/2025	05/05/2025

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1568, 70771-1569, 70771-1570, 70771-1571, 70771-1572, 70771-1573, 70771-1574, 70771-1575) , MANUFACTURE(70771-1568, 70771-1569, 70771-1570, 70771-1571, 70771-1572, 70771-1573, 70771-1574, 70771-1575)

Revised: 5/2025

Document Id: b6fd0527-ba0e-4042-b02f-4ae8f6219b4d

Set id: 94969c72-8f99-4754-ae17-0fc081591e78

Version: 4

Effective Time: 20250505

Zydus Lifesciences Limited