bexarotene

Generic: bexarotene

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

Drug Facts

Product Profile

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

bexarotene 75 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6955
Product ID 0378-6955_43459ab6-17fd-4c77-b269-4a97780af170
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203174
Listing Expiration 2026-12-31
Marketing Start 2015-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786955
Hyphenated Format 0378-6955

Supplemental Identifiers

RxCUI
308725
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 ANDA203174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01)
source: ndc

Packages (1)

0378-6955-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01)

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": "43459ab6-17fd-4c77-b269-4a97780af170", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["A61RXM4375"], "rxcui": ["308725"], "spl_set_id": ["2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5"], "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": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01)", "package_ndc": "0378-6955-01", "marketing_start_date": "20150709"}], "brand_name": "Bexarotene", "product_id": "0378-6955_43459ab6-17fd-4c77-b269-4a97780af170", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0378-6955", "generic_name": "Bexarotene", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bexarotene", "active_ingredients": [{"name": "BEXAROTENE", "strength": "75 mg/1"}], "application_number": "ANDA203174", "marketing_category": "ANDA", "marketing_start_date": "20150709", "listing_expiration_date": "20261231"}