Label: ISOTRETINOIN capsule
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NDC Code(s):
70771-1662-2,
70771-1662-8,
70771-1663-2,
70771-1663-8, view more70771-1664-2, 70771-1664-8, 70771-1665-2, 70771-1665-8, 70771-1666-2, 70771-1666-8, 70771-1667-2, 70771-1667-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 4, 2025
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Isotretinoin Capsules USP, 10 mg
30 Capsules
Rx only
Isotretinoin Capsules USP, 20 mg
30 Capsules
Rx only
Isotretinoin Capsules USP, 25 mg
30 Capsules
Rx only
Isotretinoin Capsules USP, 30 mg
30 Capsules
Rx only
Isotretinoin Capsules USP, 35 mg
30 Capsules
Rx only
Isotretinoin Capsules USP, 40 mg
30 Capsules
Rx only
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INGREDIENTS AND APPEARANCE
ISOTRETINOIN
isotretinoin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1662 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN 10 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (yellow opaque cap) , YELLOW (yellow opaque body) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 1574 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1662-8 3 in 1 CARTON 06/09/2025 1 NDC:70771-1662-2 10 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 ANDA216633 06/09/2025 ISOTRETINOIN
isotretinoin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1663 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN 20 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE (orange opaque cap) , ORANGE (orange opaque body) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 1575 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1663-8 3 in 1 CARTON 06/09/2025 1 NDC:70771-1663-2 10 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 ANDA216633 06/09/2025 ISOTRETINOIN
isotretinoin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1664 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN 25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color GREEN (light green opaque cap) , GREEN (light green opaque body) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 1576 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1664-8 3 in 1 CARTON 06/09/2025 1 NDC:70771-1664-2 10 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 ANDA216633 06/09/2025 ISOTRETINOIN
isotretinoin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1665 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN 30 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color BROWN (light brown opaque cap) , BROWN (light brown opaque body) Score no score Shape CAPSULE Size 24mm Flavor Imprint Code 1577 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1665-8 3 in 1 CARTON 06/09/2025 1 NDC:70771-1665-2 10 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 ANDA216633 06/09/2025 ISOTRETINOIN
isotretinoin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1666 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN 35 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE (light blue opaque cap) , BLUE (light blue opaque body) Score no score Shape CAPSULE Size 24mm Flavor Imprint Code 1578 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1666-8 3 in 1 CARTON 06/09/2025 1 NDC:70771-1666-2 10 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 ANDA216633 06/09/2025 ISOTRETINOIN
isotretinoin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1667 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN 40 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color PINK (light pink opaque cap) , PINK (light pink opaque body) Score no score Shape CAPSULE Size 24mm Flavor Imprint Code 1579 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1667-8 3 in 1 CARTON 06/09/2025 1 NDC:70771-1667-2 10 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 ANDA216633 06/09/2025 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1662, 70771-1663, 70771-1664, 70771-1665, 70771-1666, 70771-1667) , MANUFACTURE(70771-1662, 70771-1663, 70771-1664, 70771-1665, 70771-1666, 70771-1667)