BRIVARACETAM tablet, film coated
brivaracetam by
Drug Labeling and Warnings
brivaracetam by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- SPL MEDGUIDE
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 70771-1754-6
Brivaracetam tablets, 10 mg - CV
60 Tablets
Rx only
NDC: 70771-1755-6
Brivaracetam tablets, 25 mg - CV
60 Tablets
Rx only
NDC: 70771-1756-6
Brivaracetam tablets, 50 mg - CV
60 Tablets
Rx only
NDC: 70771-1757-6
Brivaracetam tablets, 75 mg - CV
60 Tablets
Rx only
NDC: 70771-1758-6
Brivaracetam tablets, 100 mg - CV
60 Tablets
Rx only
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INGREDIENTS AND APPEARANCE
BRIVARACETAM
brivaracetam tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1754 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRIVARACETAM (UNII: U863JGG2IA) (BRIVARACETAM - UNII:U863JGG2IA) BRIVARACETAM 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1754-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 2 NDC: 70771-1754-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 3 NDC: 70771-1754-4 100 in 1 CARTON 01/21/2026 3 NDC: 70771-1754-7 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214501 01/21/2026 BRIVARACETAM
brivaracetam tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1755 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRIVARACETAM (UNII: U863JGG2IA) (BRIVARACETAM - UNII:U863JGG2IA) BRIVARACETAM 25 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (light blue) Score no score Shape OVAL Size 9mm Flavor Imprint Code U1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1755-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 2 NDC: 70771-1755-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 3 NDC: 70771-1755-4 100 in 1 CARTON 01/21/2026 3 NDC: 70771-1755-7 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214501 01/21/2026 BRIVARACETAM
brivaracetam tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1756 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRIVARACETAM (UNII: U863JGG2IA) (BRIVARACETAM - UNII:U863JGG2IA) BRIVARACETAM 50 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (off-white) Score no score Shape OVAL Size 12mm Flavor Imprint Code U11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1756-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 2 NDC: 70771-1756-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 3 NDC: 70771-1756-4 100 in 1 CARTON 01/21/2026 3 NDC: 70771-1756-7 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214501 01/21/2026 BRIVARACETAM
brivaracetam tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1757 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRIVARACETAM (UNII: U863JGG2IA) (BRIVARACETAM - UNII:U863JGG2IA) BRIVARACETAM 75 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) BLUE 1 LAKE (UNII: J9EQA3S2JM) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PURPLE Score no score Shape OVAL Size 13mm Flavor Imprint Code 1587 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1757-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 2 NDC: 70771-1757-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 3 NDC: 70771-1757-4 100 in 1 CARTON 01/21/2026 3 NDC: 70771-1757-7 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214501 01/21/2026 BRIVARACETAM
brivaracetam tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1758 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRIVARACETAM (UNII: U863JGG2IA) (BRIVARACETAM - UNII:U863JGG2IA) BRIVARACETAM 100 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) BLUE 1 LAKE (UNII: J9EQA3S2JM) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (light-green) Score no score Shape OVAL Size 15mm Flavor Imprint Code 1588 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1758-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 2 NDC: 70771-1758-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2026 3 NDC: 70771-1758-4 100 in 1 CARTON 01/21/2026 3 NDC: 70771-1758-7 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214501 01/21/2026 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1754, 70771-1755, 70771-1756, 70771-1757, 70771-1758) , MANUFACTURE(70771-1754, 70771-1755, 70771-1756, 70771-1757, 70771-1758)
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