isotretinoin

Generic: isotretinoin

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler mayne pharma
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 68308-575
Product ID 68308-575_52056651-f1ce-4586-9c28-f919591060a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213571
Listing Expiration 2026-12-31
Marketing Start 2021-09-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308575
Hyphenated Format 68308-575

Supplemental Identifiers

RxCUI
197845
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 ANDA213571 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 BOX (68308-575-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01)
source: ndc

Packages (1)

68308-575-30 3 BLISTER PACK in 1 BOX (68308-575-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01)

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": "52056651-f1ce-4586-9c28-f919591060a4", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197845"], "spl_set_id": ["72867c88-070f-4608-bfef-cc5225ebce6d"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 BOX (68308-575-30)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01)", "package_ndc": "68308-575-30", "marketing_start_date": "20210903"}], "brand_name": "Isotretinoin", "product_id": "68308-575_52056651-f1ce-4586-9c28-f919591060a4", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68308-575", "generic_name": "Isotretinoin", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "40 mg/1"}], "application_number": "ANDA213571", "marketing_category": "ANDA", "marketing_start_date": "20210903", "listing_expiration_date": "20261231"}