isotretinoin

Generic: isotretinoin

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1579
Product ID 70710-1579_a5b78223-8bce-490b-a83c-e342c25c082a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216633
Listing Expiration 2026-12-31
Marketing Start 2025-06-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101579
Hyphenated Format 70710-1579

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 ANDA216633 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (70710-1579-8) / 10 CAPSULE in 1 BLISTER PACK (70710-1579-2)
source: ndc

Packages (1)

70710-1579-8 3 BLISTER PACK in 1 CARTON (70710-1579-8) / 10 CAPSULE in 1 BLISTER PACK (70710-1579-2)

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": "a5b78223-8bce-490b-a83c-e342c25c082a", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1547561", "1547565"], "spl_set_id": ["31f62a49-4c6d-4ce3-a0ca-d159562370b1"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70710-1579-8)  / 10 CAPSULE in 1 BLISTER PACK (70710-1579-2)", "package_ndc": "70710-1579-8", "marketing_start_date": "20250609"}], "brand_name": "Isotretinoin", "product_id": "70710-1579_a5b78223-8bce-490b-a83c-e342c25c082a", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "70710-1579", "generic_name": "Isotretinoin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "40 mg/1"}], "application_number": "ANDA216633", "marketing_category": "ANDA", "marketing_start_date": "20250609", "listing_expiration_date": "20261231"}