DailyMed - TOPIRAMATE capsule, extended release

NDC Code(s): 70771-1656-3, 70771-1656-9, 70771-1657-3, 70771-1657-9, view more
70771-1658-3, 70771-1658-9, 70771-1659-3, 70771-1659-9, 70771-1660-3, 70771-1660-9
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 28, 2023

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SPL UNCLASSIFIED SECTION
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1656-3

Topiramate extended-release Capsules 25 mg

Rx only

30 Capsules

NDC 70771-1657-3

Topiramate extended-release Capsules 50 mg

Rx only

30 Capsules

NDC 70771-1658-3

Topiramate extended-release Capsules 100 mg

Rx only

30 Capsules

NDC 70771-1659-3

Topiramate extended-release Capsules 150 mg

Rx only

30 Capsules

NDC 70771-1660-3

Topiramate extended-release Capsules 200 mg

Rx only

30 Capsules

INGREDIENTS AND APPEARANCE

TOPIRAMATE
topiramate capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1656
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	25 mg

Ingredient Name	Strength
Inactive Ingredients
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK (FLESH OPAQUE CAP) , WHITE (WHITE OPAQUE BODY)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	14mm
Flavor		Imprint Code	1039
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1656-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023
2	NDC:70771-1656-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208949	01/17/2023

TOPIRAMATE
topiramate capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1657
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (IVORY OPAQUE CAP) , WHITE (WHITE OPAQUE BODY)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	1040
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1657-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023
2	NDC:70771-1657-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208949	01/17/2023

TOPIRAMATE
topiramate capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1658
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	100 mg

Ingredient Name	Strength
Inactive Ingredients
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE (MEDIUM ORANGE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	1041
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1658-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023
2	NDC:70771-1658-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208949	01/17/2023

TOPIRAMATE
topiramate capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1659
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	150 mg

Ingredient Name	Strength
Inactive Ingredients
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (WHITE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	22mm
Flavor		Imprint Code	1042
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1659-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023
2	NDC:70771-1659-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208949	01/17/2023

TOPIRAMATE
topiramate capsule, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1660
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	200 mg

Ingredient Name	Strength
Inactive Ingredients
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	GREEN (LIGHT GREEN OPAQUE CAP) , WHITE (WHITE OPAQUE BODY)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	23mm
Flavor		Imprint Code	1043
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1660-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023
2	NDC:70771-1660-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208949	01/17/2023

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1656, 70771-1657, 70771-1658, 70771-1659, 70771-1660) , MANUFACTURE(70771-1656, 70771-1657, 70771-1658, 70771-1659, 70771-1660)

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Published Date (What is this?)	Version	Files
Sep 28, 2023	3 (current)	download
Jan 17, 2023	2	download

	RxCUI	RxNorm NAME	RxTTY
1	1494769	topiramate 150 MG Sprinkle 24HR Extended Release Oral Capsule	PSN
2	1494769	Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule	SCD
3	1494769	topiramate 150 MG Sprinkle 24 HR Extended Release Oral Capsule	SY
4	1812419	topiramate 200 MG Sprinkle 24HR Extended Release Oral Capsule	PSN
5	1812419	Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule	SCD
6	1812419	topiramate 200 MG Sprinkle 24 HR Extended Release Oral Capsule	SY
7	1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	PSN
8	1812421	Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule	SCD
9	1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	SY
10	1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	PSN
11	1812425	Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule	SCD
12	1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	SY
13	1812427	topiramate 100 MG Sprinkle 24HR Extended Release Oral Capsule	PSN
14	1812427	Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule	SCD
15	1812427	topiramate 100 MG Sprinkle 24 HR Extended Release Oral Capsule	SY

Label: TOPIRAMATE capsule, extended release

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	NDC
1	70771-1656-3
2	70771-1656-9
3	70771-1657-3
4	70771-1657-9
5	70771-1658-3
6	70771-1658-9
7	70771-1659-3
8	70771-1659-9
9	70771-1660-3
10	70771-1660-9

Label: TOPIRAMATE capsule, extended release

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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Safety

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More Info on this Drug

TOPIRAMATE capsule, extended release

Number of versions: 2

TOPIRAMATE capsule, extended release

TOPIRAMATE capsule, extended release

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TOPIRAMATE capsule, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.