accutane

Generic: isotretinoin

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

Drug Facts

Product Profile

Brand Name accutane
Generic Name isotretinoin
Labeler jg pharma inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

isotretinoin 10 mg/1

Manufacturer
JG Pharma Inc.

Identifiers & Regulatory

Product NDC 72143-251
Product ID 72143-251_499b3a69-1651-0f27-e063-6294a90a49eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202099
Listing Expiration 2027-12-31
Marketing Start 2022-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72143251
Hyphenated Format 72143-251

Supplemental Identifiers

RxCUI
197843 197844 197845 206880 206883 206902 403930 2473107
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 accutane (source: ndc)
Generic Name isotretinoin (source: ndc)
Application Number ANDA202099 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (72143-251-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK
source: ndc

Packages (1)

72143-251-30 3 BLISTER PACK in 1 CARTON (72143-251-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK

Ingredients (1)

isotretinoin (10 mg/1)

Linked Drug Pages (1)

ACCUTANE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "499b3a69-1651-0f27-e063-6294a90a49eb", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "206880", "206883", "206902", "403930", "2473107"], "spl_set_id": ["5b524a51-a16b-496e-b764-11c98c479c36"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["JG Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (72143-251-30)  / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK", "package_ndc": "72143-251-30", "marketing_start_date": "20220801"}], "brand_name": "ACCUTANE", "product_id": "72143-251_499b3a69-1651-0f27-e063-6294a90a49eb", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "72143-251", "generic_name": "ISOTRETINOIN", "labeler_name": "JG Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACCUTANE", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "10 mg/1"}], "application_number": "ANDA202099", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20271231"}