acitretin

Generic: acitretin

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acitretin
Generic Name acitretin
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acitretin 25 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-743
Product ID 46708-743_77011f2b-a2e7-4a43-9ff3-29d73f322319
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217774
Listing Expiration 2026-12-31
Marketing Start 2024-08-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708743
Hyphenated Format 46708-743

Supplemental Identifiers

RxCUI
199689 199690 894859
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 ANDA217774 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (46708-743-30)
source: ndc

Packages (1)

46708-743-30 30 CAPSULE in 1 BOTTLE (46708-743-30)

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": "77011f2b-a2e7-4a43-9ff3-29d73f322319", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["LCH760E9T7"], "rxcui": ["199689", "199690", "894859"], "spl_set_id": ["77011f2b-a2e7-4a43-9ff3-29d73f322319"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-743-30)", "package_ndc": "46708-743-30", "marketing_start_date": "20240808"}], "brand_name": "Acitretin", "product_id": "46708-743_77011f2b-a2e7-4a43-9ff3-29d73f322319", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "46708-743", "generic_name": "Acitretin", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acitretin", "active_ingredients": [{"name": "ACITRETIN", "strength": "25 mg/1"}], "application_number": "ANDA217774", "marketing_category": "ANDA", "marketing_start_date": "20240808", "listing_expiration_date": "20261231"}