sohonos

Generic: palovarotene

Labeler: ipsen biopharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sohonos
Generic Name palovarotene
Labeler ipsen biopharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

palovarotene 5 mg/1

Manufacturer
Ipsen Biopharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 15054-0050
Product ID 15054-0050_5bd9a571-7061-4cc7-bda8-18a9976dd427
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215559
Listing Expiration 2026-12-31
Marketing Start 2023-08-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 150540050
Hyphenated Format 15054-0050

Supplemental Identifiers

RxCUI
2663960 2663966 2663968 2663970 2663972 2663974 2663976 2663978 2663980 2663982
UNII
28K6I5M16G
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 sohonos (source: ndc)
Generic Name palovarotene (source: ndc)
Application Number NDA215559 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (15054-0050-1) / 14 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

15054-0050-1 1 BLISTER PACK in 1 CARTON (15054-0050-1) / 14 CAPSULE in 1 BLISTER PACK

Ingredients (1)

palovarotene (5 mg/1)

Linked Drug Pages (1)

SOHONOS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5bd9a571-7061-4cc7-bda8-18a9976dd427", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["28K6I5M16G"], "rxcui": ["2663960", "2663966", "2663968", "2663970", "2663972", "2663974", "2663976", "2663978", "2663980", "2663982"], "spl_set_id": ["67dce406-7cc4-4d66-92de-ad18b6df0625"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Ipsen Biopharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (15054-0050-1)  / 14 CAPSULE in 1 BLISTER PACK", "package_ndc": "15054-0050-1", "marketing_start_date": "20230816"}], "brand_name": "SOHONOS", "product_id": "15054-0050_5bd9a571-7061-4cc7-bda8-18a9976dd427", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "15054-0050", "generic_name": "palovarotene", "labeler_name": "Ipsen Biopharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOHONOS", "active_ingredients": [{"name": "PALOVAROTENE", "strength": "5 mg/1"}], "application_number": "NDA215559", "marketing_category": "NDA", "marketing_start_date": "20230816", "listing_expiration_date": "20261231"}