ISOTRETINOIN- isotretinoin capsule 
Zydus Lifesciences Limited

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Isotretinoin Capsules, USP
Rx Only


CAUSES BIRTH DEFECTS

.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1557-8

Isotretinoin Capsules, USP 10 mg

30 Capsules

Rx only

10 mg front label
10 mg back

NDC 70771-1558-8

Isotretinoin Capsules, USP 20 mg

30 Capsules

Rx only

20 mg front
20 mg back

NDC 70771-1559-8

Isotretinoin Capsules, USP 30 mg

30 Capsules

Rx only

30 mg front
30 mg back

NDC 70771-1560-8

Isotretinoin Capsules, USP 40 mg

30 Capsules

Rx only

40 mg front
40 mg back
ISOTRETINOIN 
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1557
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN10 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SOYBEAN OIL (UNII: 241ATL177A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorBROWN (reddish brown) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code 1022
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1557-83 in 1 CARTON09/12/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1557-410 in 1 CARTON09/12/2023
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21156809/12/2023
ISOTRETINOIN 
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1558
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN20 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SOYBEAN OIL (UNII: 241ATL177A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorYELLOW (CREAM) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code 1023
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1558-83 in 1 CARTON09/12/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1558-410 in 1 CARTON09/12/2023
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21156809/12/2023
ISOTRETINOIN 
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1559
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN30 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SOYBEAN OIL (UNII: 241ATL177A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
AMMONIA (UNII: 5138Q19F1X)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
ColorYELLOW (BEIGE) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code 1024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1559-83 in 1 CARTON09/12/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21156809/12/2023
ISOTRETINOIN 
isotretinoin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1560
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) ISOTRETINOIN40 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SOYBEAN OIL (UNII: 241ATL177A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorBROWN (LIGHT BROWN) Scoreno score
ShapeOVALSize14mm
FlavorImprint Code 1025
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1560-83 in 1 CARTON09/12/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1560-410 in 1 CARTON09/12/2023
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21156809/12/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1557, 70771-1558, 70771-1559, 70771-1560) , MANUFACTURE(70771-1557, 70771-1558, 70771-1559, 70771-1560)

Revised: 11/2024
Document Id: b071eb5c-28f7-4b86-b4e9-7c98da2f19df
Set id: dae33df0-386c-4db5-9759-7096e770ed17
Version: 2
Effective Time: 20241130
 
Zydus Lifesciences Limited