isotretinoin

Generic: isotretinoin

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-0575
Product ID 0245-0575_51287574-9a83-45db-9b8d-cc8bcb8a44db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213571
Listing Expiration 2026-12-31
Marketing Start 2021-04-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02450575
Hyphenated Format 0245-0575

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 (0245-0575-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0575-89)
source: ndc

Packages (1)

0245-0575-01 3 BLISTER PACK in 1 BOX (0245-0575-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0575-89)

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": "51287574-9a83-45db-9b8d-cc8bcb8a44db", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197845"], "spl_set_id": ["ff1edbb8-ac0e-4563-9c2a-94385ce055e3"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 BOX (0245-0575-01)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0575-89)", "package_ndc": "0245-0575-01", "marketing_start_date": "20210625"}], "brand_name": "Isotretinoin", "product_id": "0245-0575_51287574-9a83-45db-9b8d-cc8bcb8a44db", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0245-0575", "generic_name": "Isotretinoin", "labeler_name": "Upsher-Smith Laboratories, LLC", "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": "20210412", "listing_expiration_date": "20261231"}