acitretin

Generic: acitretin

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acitretin
Generic Name acitretin
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acitretin 25 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-088
Product ID 42291-088_0e8b3503-2371-af12-e063-6294a90af0c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204633
Listing Expiration 2026-12-31
Marketing Start 2017-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291088
Hyphenated Format 42291-088

Supplemental Identifiers

RxCUI
199689 199690 894859
UPC
0342291086302 0342291087309 0342291088306
UNII
LCH760E9T7
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 acitretin (source: ndc)
Generic Name acitretin (source: ndc)
Application Number ANDA204633 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (42291-088-30)
source: ndc

Packages (1)

42291-088-30 30 CAPSULE in 1 BOTTLE (42291-088-30)

Ingredients (1)

acitretin (25 mg/1)

Linked Drug Pages (1)

ACITRETIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e8b3503-2371-af12-e063-6294a90af0c0", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0342291086302", "0342291087309", "0342291088306"], "unii": ["LCH760E9T7"], "rxcui": ["199689", "199690", "894859"], "spl_set_id": ["6af396c2-af3e-436d-ba9a-583637495910"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42291-088-30)", "package_ndc": "42291-088-30", "marketing_start_date": "20171011"}], "brand_name": "ACITRETIN", "product_id": "42291-088_0e8b3503-2371-af12-e063-6294a90af0c0", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "42291-088", "generic_name": "ACITRETIN", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACITRETIN", "active_ingredients": [{"name": "ACITRETIN", "strength": "25 mg/1"}], "application_number": "ANDA204633", "marketing_category": "ANDA", "marketing_start_date": "20171011", "listing_expiration_date": "20261231"}