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NDC 64370-0375-01 HEMANGEOL 4.28 mg/mL Details
HEMANGEOL 4.28 mg/mL
HEMANGEOL is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pierre Fabre Pharmaceuticals, Inc.. The primary component is PROPRANOLOL HYDROCHLORIDE.
MedlinePlus Drug Summary
Propranolol oral solution is used to treat proliferating infantile hemangioma (benign [noncancerous] growths or tumors appearing on or under the skin shortly after birth) in infants 5 weeks to 5 months of age. Propranolol is in a class of medications called beta blockers. It works by narrowing the blood vessels already formed and by preventing new ones from growing.
Related Packages: 64370-0375-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Propranolol (Infantile Hemangioma)
Product Information
| NDC | 64370-0375 |
|---|---|
| Product ID | 64370-375_f80d1fd4-6040-93b1-e053-6294a90a786a |
| Associated GPIs | 33100040102080 |
| GCN Sequence Number | 072352 |
| GCN Sequence Number Description | propranolol HCl SOLUTION 4.28 MG/ML ORAL |
| HIC3 | J7C |
| HIC3 Description | BETA-ADRENERGIC BLOCKING AGENTS |
| GCN | 36526 |
| HICL Sequence Number | 002101 |
| HICL Sequence Number Description | PROPRANOLOL HCL |
| Brand/Generic | Brand |
| Proprietary Name | HEMANGEOL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | propranolol hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 4.28 |
| Active Ingredient Units | mg/mL |
| Substance Name | PROPRANOLOL HYDROCHLORIDE |
| Labeler Name | Pierre Fabre Pharmaceuticals, Inc. |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA205410 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64370-0375-01 (64370037501)
| NDC Package Code | 64370-375-01 |
|---|---|
| Billing NDC | 64370037501 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (64370-375-01) / 120 mL in 1 BOTTLE, GLASS |
| Marketing Start Date | 2014-04-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |