PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1348-1 in bottle of 100 tablets

Methylprednisolone tablets, USP

Rx only

100 tablets

NDC 70771-1349-8 in bottle of 25 tablets

Methylprednisolone tablets, USP

Rx only

25 tablets

NDC 70771-1350-7 in bottle of 50 tablets

Methylprednisolone tablets, USP

Rx only

50 tablets

NDC 70771-1351-8 in bottle of 25 tablets

Methylprednisolone tablets, USP

Rx only

25 tablets

METHYLPREDNISOLONE
methylprednisolone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1348
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)	METHYLPREDNISOLONE	4 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	4 pieces
Shape	OVAL (OVAL)	Size	8mm
Flavor		Imprint Code	916
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1348-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
2	NDC:70771-1348-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
3	NDC:70771-1348-3	1 in 1 CARTON	05/01/2018
3		21 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	ANDA206751	05/01/2018

METHYLPREDNISOLONE
methylprednisolone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1349
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)	METHYLPREDNISOLONE	8 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	OVAL (OVAL)	Size	10mm
Flavor		Imprint Code	917
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1349-8	25 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
2	NDC:70771-1349-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
3	NDC:70771-1349-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
4	NDC:70771-1349-4	10 in 1 CARTON	05/01/2018
4	NDC:70771-1349-2	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	ANDA206751	05/01/2018

METHYLPREDNISOLONE
methylprednisolone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1350
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)	METHYLPREDNISOLONE	16 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	4 pieces
Shape	OVAL (OVAL)	Size	10mm
Flavor		Imprint Code	918
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1350-7	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
2	NDC:70771-1350-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
3	NDC:70771-1350-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
4	NDC:70771-1350-4	10 in 1 CARTON	05/01/2018
4	NDC:70771-1350-2	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	ANDA206751	05/01/2018

METHYLPREDNISOLONE
methylprednisolone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1351
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)	METHYLPREDNISOLONE	32 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	OVAL (OVAL)	Size	14mm
Flavor		Imprint Code	919
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1351-8	25 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
2	NDC:70771-1351-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
3	NDC:70771-1351-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2018
4	NDC:70771-1351-4	10 in 1 CARTON	05/01/2018
4	NDC:70771-1351-2	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	ANDA206751	05/01/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1348, 70771-1349, 70771-1350, 70771-1351) , MANUFACTURE(70771-1348, 70771-1349, 70771-1350, 70771-1351)

Methylprednisolone Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL