isotretinoin

Generic: isotretinoin

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler zydus lifesciences limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1560
Product ID 70771-1560_b071eb5c-28f7-4b86-b4e9-7c98da2f19df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211568
Listing Expiration 2026-12-31
Marketing Start 2023-09-12

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711560
Hyphenated Format 70771-1560

Supplemental Identifiers

RxCUI
197843 197844 197845 403930
UNII
EH28UP18IF
NUI
N0000175607 M0018962

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isotretinoin (source: ndc)
Generic Name isotretinoin (source: ndc)
Application Number ANDA211568 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (70771-1560-4) / 10 CAPSULE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (70771-1560-8) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

70771-1560-4 10 BLISTER PACK in 1 CARTON (70771-1560-4) / 10 CAPSULE in 1 BLISTER PACK 70771-1560-8 3 BLISTER PACK in 1 CARTON (70771-1560-8) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

isotretinoin (40 mg/1)

Linked Drug Pages (1)

Isotretinoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b071eb5c-28f7-4b86-b4e9-7c98da2f19df", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930"], "spl_set_id": ["dae33df0-386c-4db5-9759-7096e770ed17"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1560-4)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "70771-1560-4", "marketing_start_date": "20230912"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70771-1560-8)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "70771-1560-8", "marketing_start_date": "20230912"}], "brand_name": "Isotretinoin", "product_id": "70771-1560_b071eb5c-28f7-4b86-b4e9-7c98da2f19df", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "70771-1560", "generic_name": "Isotretinoin", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "40 mg/1"}], "application_number": "ANDA211568", "marketing_category": "ANDA", "marketing_start_date": "20230912", "listing_expiration_date": "20261231"}