isotretinoin

Generic: isotretinoin

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1176
Product ID 69238-1176_c2645360-e4a8-4737-9065-3dbbd4b6e6b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207792
Listing Expiration 2026-12-31
Marketing Start 2017-10-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381176
Hyphenated Format 69238-1176

Supplemental Identifiers

RxCUI
197843 197844 197845 403930
UPC
0369238117530 0369238117615 0369238117639 0369238117417 0369238117516 0369238117431 0369238101737 0369238101713
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 ANDA207792 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (69238-1176-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1176-1)
source: ndc

Packages (1)

69238-1176-3 3 BLISTER PACK in 1 CARTON (69238-1176-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1176-1)

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": "c2645360-e4a8-4737-9065-3dbbd4b6e6b7", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0369238117530", "0369238117615", "0369238117639", "0369238117417", "0369238117516", "0369238117431", "0369238101737", "0369238101713"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930"], "spl_set_id": ["c2917c3d-3499-48a0-ba53-120cb979195d"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (69238-1176-3)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1176-1)", "package_ndc": "69238-1176-3", "marketing_start_date": "20171002"}], "brand_name": "Isotretinoin", "product_id": "69238-1176_c2645360-e4a8-4737-9065-3dbbd4b6e6b7", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "69238-1176", "generic_name": "Isotretinoin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "40 mg/1"}], "application_number": "ANDA207792", "marketing_category": "ANDA", "marketing_start_date": "20171002", "listing_expiration_date": "20261231"}