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
Routes
ORAL
Active Ingredients

isotretinoin 20 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1255
Product ID 69238-1255_831e90e7-4cd9-44e1-8f94-b136bcba2b5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216097
Listing Expiration 2026-12-31
Marketing Start 2025-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381255
Hyphenated Format 69238-1255

Supplemental Identifiers

RxCUI
197843 197844 197845 403930 1547561 1547565
UPC
0369238125443 0369238125948 0369238125641 0369238125542 0369238125849 0369238125740
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 ANDA216097 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 BOX (69238-1255-3) / 10 CAPSULE in 1 BLISTER PACK (69238-1255-4)
source: ndc

Packages (1)

69238-1255-3 3 BLISTER PACK in 1 BOX (69238-1255-3) / 10 CAPSULE in 1 BLISTER PACK (69238-1255-4)

Ingredients (1)

isotretinoin (20 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": "831e90e7-4cd9-44e1-8f94-b136bcba2b5b", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0369238125443", "0369238125948", "0369238125641", "0369238125542", "0369238125849", "0369238125740"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1547561", "1547565"], "spl_set_id": ["9f1c8971-c6dc-4708-848b-5cee50b6c32a"], "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 BOX (69238-1255-3)  / 10 CAPSULE in 1 BLISTER PACK (69238-1255-4)", "package_ndc": "69238-1255-3", "marketing_start_date": "20251010"}], "brand_name": "Isotretinoin", "product_id": "69238-1255_831e90e7-4cd9-44e1-8f94-b136bcba2b5b", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "69238-1255", "generic_name": "Isotretinoin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "20 mg/1"}], "application_number": "ANDA216097", "marketing_category": "ANDA", "marketing_start_date": "20251010", "listing_expiration_date": "20261231"}