Label: LENALIDOMIDE capsule
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NDC Code(s):
70771-1676-1,
70771-1676-7,
70771-1677-1,
70771-1677-7, view more70771-1678-1, 70771-1678-7, 70771-1679-1, 70771-1679-8, 70771-1680-1, 70771-1680-8, 70771-1681-1, 70771-1681-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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- SPL UNCLASSIFIED SECTION
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LENALIDOMIDE
lenalidomide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1677 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white opaque cap with white opaque body) Score no score Shape CAPSULE (capsule) Size 11mm Flavor Imprint Code 1031 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1677-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 2 NDC:70771-1677-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210154 09/12/2022 LENALIDOMIDE
lenalidomide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1678 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 33 (UNII: 9DBA0SBB0L) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White opaque cap) , BLUE (Turquoise blue opaque body) Score no score Shape CAPSULE (capsule) Size 16mm Flavor Imprint Code 1032 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1678-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 2 NDC:70771-1678-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210154 09/12/2022 LENALIDOMIDE
lenalidomide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1679 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 15 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White opaque cap) , BLUE (Light Blue opaque body) Score no score Shape CAPSULE (capsule) Size 18mm Flavor Imprint Code 1033 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1679-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 2 NDC:70771-1679-8 21 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210154 09/12/2022 LENALIDOMIDE
lenalidomide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1681 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White opaque cap) , BLUE (Light Blue opaque body) Score no score Shape CAPSULE (capsule) Size 22mm Flavor Imprint Code 1035 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1681-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 2 NDC:70771-1681-8 21 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210154 09/12/2022 LENALIDOMIDE
lenalidomide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1676 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 2.5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white opaque cap with blue opaque body) Score no score Shape CAPSULE (capsule) Size 11mm Flavor Imprint Code 1030 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1676-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2023 2 NDC:70771-1676-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210154 03/07/2023 LENALIDOMIDE
lenalidomide capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1680 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4) LENALIDOMIDE 20 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 33 (UNII: 9DBA0SBB0L) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (light blue opaque cap turquoise blue opaque body) Score no score Shape CAPSULE (capsule) Size 19mm Flavor Imprint Code 1034 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1680-8 21 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2023 2 NDC:70771-1680-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210154 03/07/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1676, 70771-1677, 70771-1678, 70771-1679, 70771-1680, 70771-1681) , MANUFACTURE(70771-1676, 70771-1677, 70771-1678, 70771-1679, 70771-1680, 70771-1681)
