isotretinoin

Generic: isotretinoin

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler actavis pharma, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2436
Product ID 0591-2436_2f164fd8-4912-4149-9292-0dc2249a69a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205063
Listing Expiration 2026-12-31
Marketing Start 2021-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05912436
Hyphenated Format 0591-2436

Supplemental Identifiers

RxCUI
197843 197844 197845 403930 1547561 1547565
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 ANDA205063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0591-2436-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2436-45)
source: ndc

Packages (1)

0591-2436-15 3 BLISTER PACK in 1 CARTON (0591-2436-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2436-45)

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": "2f164fd8-4912-4149-9292-0dc2249a69a3", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1547561", "1547565"], "spl_set_id": ["1cf11710-f966-4529-8e08-02175f588bca"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0591-2436-15)  / 10 CAPSULE in 1 BLISTER PACK (0591-2436-45)", "package_ndc": "0591-2436-15", "marketing_start_date": "20210429"}], "brand_name": "Isotretinoin", "product_id": "0591-2436_2f164fd8-4912-4149-9292-0dc2249a69a3", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0591-2436", "generic_name": "Isotretinoin", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "40 mg/1"}], "application_number": "ANDA205063", "marketing_category": "ANDA", "marketing_start_date": "20210429", "listing_expiration_date": "20261231"}