acitretin

Generic: acitretin

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acitretin
Generic Name acitretin
Labeler sigmapharm laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acitretin 25 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-083
Product ID 42794-083_f1f1dd05-77f9-ff40-e053-2995a90a2e80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204633
Listing Expiration 2026-12-31
Marketing Start 2015-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42794083
Hyphenated Format 42794-083

Supplemental Identifiers

RxCUI
199689 199690 894859
UPC
0342794080081 0342794081088 0342794083082
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 (42794-083-08)
source: ndc

Packages (1)

42794-083-08 30 CAPSULE in 1 BOTTLE (42794-083-08)

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": "f1f1dd05-77f9-ff40-e053-2995a90a2e80", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0342794080081", "0342794081088", "0342794083082"], "unii": ["LCH760E9T7"], "rxcui": ["199689", "199690", "894859"], "spl_set_id": ["a6546625-acb8-460e-b34e-f795bfb3680a"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42794-083-08)", "package_ndc": "42794-083-08", "marketing_start_date": "20150916"}], "brand_name": "ACITRETIN", "product_id": "42794-083_f1f1dd05-77f9-ff40-e053-2995a90a2e80", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "42794-083", "generic_name": "ACITRETIN", "labeler_name": "Sigmapharm Laboratories, LLC", "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": "20150916", "listing_expiration_date": "20261231"}