isotretinoin

Generic: isotretinoin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-636
Product ID 59651-636_b861fc3d-a8b7-473f-bca1-b0e6269a0683
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218194
Listing Expiration 2026-12-31
Marketing Start 2024-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651636
Hyphenated Format 59651-636

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 ANDA218194 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (59651-636-03) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

59651-636-03 3 BLISTER PACK in 1 CARTON (59651-636-03) / 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": "b861fc3d-a8b7-473f-bca1-b0e6269a0683", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1547561", "1547565"], "spl_set_id": ["4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (59651-636-03)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "59651-636-03", "marketing_start_date": "20240129"}], "brand_name": "ISOTRETINOIN", "product_id": "59651-636_b861fc3d-a8b7-473f-bca1-b0e6269a0683", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "59651-636", "generic_name": "ISOTRETINOIN", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOTRETINOIN", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "40 mg/1"}], "application_number": "ANDA218194", "marketing_category": "ANDA", "marketing_start_date": "20240129", "listing_expiration_date": "20261231"}