acitretin

Generic: acitretin

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acitretin
Generic Name acitretin
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acitretin 10 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-1135
Product ID 0093-1135_11579624-a4a1-4db1-bf72-9fbedbce3225
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091455
Listing Expiration 2026-12-31
Marketing Start 2013-07-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00931135
Hyphenated Format 0093-1135

Supplemental Identifiers

RxCUI
199689 199690 894859
UPC
0300931138569 0300931135568
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 ANDA091455 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (0093-1135-56)
source: ndc

Packages (1)

0093-1135-56 30 CAPSULE in 1 BOTTLE (0093-1135-56)

Ingredients (1)

acitretin (10 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": "11579624-a4a1-4db1-bf72-9fbedbce3225", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0300931138569", "0300931135568"], "unii": ["LCH760E9T7"], "rxcui": ["199689", "199690", "894859"], "spl_set_id": ["993a5325-cd10-4450-b5ea-1c0a90510df6"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0093-1135-56)", "package_ndc": "0093-1135-56", "marketing_start_date": "20130719"}], "brand_name": "Acitretin", "product_id": "0093-1135_11579624-a4a1-4db1-bf72-9fbedbce3225", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0093-1135", "generic_name": "Acitretin", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acitretin", "active_ingredients": [{"name": "ACITRETIN", "strength": "10 mg/1"}], "application_number": "ANDA091455", "marketing_category": "ANDA", "marketing_start_date": "20130719", "listing_expiration_date": "20261231"}