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NDC 00054-3730-63 Propranolol Hydrochloride 40 mg/5mL Details
Propranolol Hydrochloride 40 mg/5mL
Propranolol Hydrochloride is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA 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: 00054-3730-63Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Propranolol (Infantile Hemangioma)
Product Information
NDC | 00054-3730 |
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Product ID | 0054-3730_09bbc997-1a8a-4e70-afbe-89971b48a7da |
Associated GPIs | 33100040102060 |
GCN Sequence Number | 005121 |
GCN Sequence Number Description | propranolol HCl SOLUTION 40MG/5ML ORAL |
HIC3 | J7C |
HIC3 Description | BETA-ADRENERGIC BLOCKING AGENTS |
GCN | 45261 |
HICL Sequence Number | 002101 |
HICL Sequence Number Description | PROPRANOLOL HCL |
Brand/Generic | Generic |
Proprietary Name | Propranolol Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Propranolol Hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION |
Route | ORAL |
Active Ingredient Strength | 40 |
Active Ingredient Units | mg/5mL |
Substance Name | PROPRANOLOL HYDROCHLORIDE |
Labeler Name | Hikma Pharmaceuticals USA Inc. |
Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA070690 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00054-3730-63 (00054373063)
NDC Package Code | 0054-3730-63 |
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Billing NDC | 00054373063 |
Package | 500 mL in 1 BOTTLE, PLASTIC (0054-3730-63) |
Marketing Start Date | 1987-05-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |