acitretin

Generic: acitretin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acitretin
Generic Name acitretin
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acitretin 25 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7023
Product ID 0378-7023_4e629ef9-879a-443d-9397-c47962855dd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202148
Listing Expiration 2026-12-31
Marketing Start 2016-03-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787023
Hyphenated Format 0378-7023

Supplemental Identifiers

RxCUI
199689 199690
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 ANDA202148 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93)
source: ndc

Packages (1)

0378-7023-93 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93)

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": "4e629ef9-879a-443d-9397-c47962855dd8", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["LCH760E9T7"], "rxcui": ["199689", "199690"], "spl_set_id": ["2150bb0f-551b-4059-a97b-187d3ab22519"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93)", "package_ndc": "0378-7023-93", "marketing_start_date": "20160310"}], "brand_name": "Acitretin", "product_id": "0378-7023_4e629ef9-879a-443d-9397-c47962855dd8", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0378-7023", "generic_name": "acitretin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acitretin", "active_ingredients": [{"name": "ACITRETIN", "strength": "25 mg/1"}], "application_number": "ANDA202148", "marketing_category": "ANDA", "marketing_start_date": "20160310", "listing_expiration_date": "20261231"}