Isotretinoin by Zydus Lifesciences Limited ISOTRETINOIN capsule

Isotretinoin by

Drug Labeling and Warnings

Isotretinoin 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: 70771-1662-8

Isotretinoin Capsules USP, 10 mg

30 Capsules

Rx only

NDC: 70771-1663-8

Isotretinoin Capsules USP, 20 mg

30 Capsules

Rx only

NDC: 70771-1664-8

Isotretinoin Capsules USP, 25 mg

30 Capsules

Rx only

NDC: 70771-1665-8

Isotretinoin Capsules USP, 30 mg

30 Capsules

Rx only

NDC: 70771-1666-8

Isotretinoin Capsules USP, 35 mg

30 Capsules

Rx only

NDC: 70771-1667-8

Isotretinoin Capsules USP, 40 mg

30 Capsules

Rx only

INGREDIENTS AND APPEARANCE

ISOTRETINOIN 
isotretinoin capsule

Product 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 capsule

Product 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 capsule

Product 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 capsule

Product 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 capsule

Product 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 capsule

Product 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)