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NDC 64370-0375-50 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: 64370-0375-50
Last 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 64370-0375-50 (64370037550)

Pricing Information	N/A
NDC Package Code	64370-375-50
Billing NDC	64370037550
Package	1 BOTTLE, GLASS in 1 CARTON (64370-375-50) / 50 mL in 1 BOTTLE, GLASS
Marketing Start Date	2014-04-14
NDC Exclude Flag	N