NDC Code(s) : 68180-260-01, 68180-260-02, 68180-260-06, 68180-261-01, 68180-261-02, 68180-261-06
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Divalproex sodiumDivalproex sodium TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-260
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM(UNII: 644VL95AO6)
(VALPROIC ACID - UNII:614OI1Z5WI) 		VALPROIC ACID250 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
ETHYLCELLULOSE (7 MPA.S)(UNII: H3UP11403C)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code L088
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-260-01100 in 1 BOTTLE Type 0: Not a Combination Product18/09/2020
2NDC:68180-260-02500 in 1 BOTTLE Type 0: Not a Combination Product18/09/2020
3NDC:68180-260-0630 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209286 09/18/2020
Divalproex sodiumDivalproex sodium TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-261
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM(UNII: 644VL95AO6)
(VALPROIC ACID - UNII:614OI1Z5WI) 		VALPROIC ACID500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
ETHYLCELLULOSE (7 MPA.S)(UNII: H3UP11403C)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE 2208 (100000 MPA.S)(UNII: VM7F0B23ZI)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GRAY Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code L089
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-261-01100 in 1 BOTTLE Type 0: Not a Combination Product18/09/2020
2NDC:68180-261-02500 in 1 BOTTLE Type 0: Not a Combination Product18/09/2020
3NDC:68180-261-0630 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209286 09/18/2020

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 650759348 MANUFACTURE(68180-260, 68180-261), PACK(68180-260, 68180-261)

PRINCIPAL DISPLAY PANEL

NDC 68180-260-06

Bottle of 30 Tablets

Once-Daily Dosing

Divalproex Sodium Extended-release Tablets, USP

250 mg Valproic Acid Activity

Rx only

Dispense with Medication Guide provided separately to each patient.

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NDC 68180-261-06

Bottle of 30 Tablets

Once-Daily Dosing

Divalproex Sodium Extended-release Tablets, USP

500 mg Valproic Acid Activity

Rx only

Dispense with Medication Guide provided separately to each patient.

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