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NDC 15054-0010-01 SOHONOS 1 mg/1 Details
SOHONOS 1 mg/1
SOHONOS is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ipsen Biopharmaceuticals, Inc.. The primary component is PALOVAROTENE.
MedlinePlus Drug Summary
Palovarotene is used to reduce the number of new heterotrophic ossification (bony formations in muscle and soft tissue) in patients with fibrodysplasia ossificans progressive (FOP) in females aged 8 years or older or females aged 10 years or older. Palovarotene is in a class of medications called retinoids. It works by stopping the signaling responsible for heterotophic ossification.
Related Packages: 15054-0010-01Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Palovarotene
Product Information
| NDC | 15054-0010 |
|---|---|
| Product ID | 15054-0010_a370c8c8-9a5f-47df-b230-6ecbcc6dfa88 |
| Associated GPIs | |
| GCN Sequence Number | 085014 |
| GCN Sequence Number Description | palovarotene CAPSULE 1 MG ORAL |
| HIC3 | Z13 |
| HIC3 Description | RETINOIC ACID RECEPTOR (RAR) AGONISTS |
| GCN | 54449 |
| HICL Sequence Number | 049043 |
| HICL Sequence Number Description | PALOVAROTENE |
| Brand/Generic | Brand |
| Proprietary Name | SOHONOS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | palovarotene |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | PALOVAROTENE |
| Labeler Name | Ipsen Biopharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215559 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 15054-0010-01 (15054001001)
| NDC Package Code | 15054-0010-1 |
|---|---|
| Billing NDC | 15054001001 |
| Package | 1 BLISTER PACK in 1 CARTON (15054-0010-1) / 14 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2023-08-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |