bexarotene

Generic: bexarotene

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

Drug Facts

Product Profile

Brand Name bexarotene
Generic Name bexarotene
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

bexarotene 75 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43975-315
Product ID 43975-315_07544503-a705-48cb-9a86-5bb5ece3fb91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209861
Listing Expiration 2026-12-31
Marketing Start 2018-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43975315
Hyphenated Format 43975-315

Supplemental Identifiers

RxCUI
308725
UPC
0343975315107
UNII
A61RXM4375
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 bexarotene (source: ndc)
Generic Name bexarotene (source: ndc)
Application Number ANDA209861 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10)
source: ndc

Packages (1)

43975-315-10 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10)

Ingredients (1)

bexarotene (75 mg/1)

Linked Drug Pages (1)

Bexarotene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "07544503-a705-48cb-9a86-5bb5ece3fb91", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0343975315107"], "unii": ["A61RXM4375"], "rxcui": ["308725"], "spl_set_id": ["e713c60d-f623-4260-b0ca-db07e1365fd2"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10)", "package_ndc": "43975-315-10", "marketing_start_date": "20180510"}], "brand_name": "Bexarotene", "product_id": "43975-315_07544503-a705-48cb-9a86-5bb5ece3fb91", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "43975-315", "generic_name": "Bexarotene", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bexarotene", "active_ingredients": [{"name": "BEXAROTENE", "strength": "75 mg/1"}], "application_number": "ANDA209861", "marketing_category": "ANDA", "marketing_start_date": "20180510", "listing_expiration_date": "20261231"}