FDA.reportPublic FDA data

HEMANGEOL

Product NDC
64370-375
11-digit product format
643700375
Labeler code
64370
Product ID
64370-375_4629077d-5a4b-443a-e063-6294a90a48ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pierre Fabre Pharmaceuticals, Inc.
Application
NDA205410
Marketing category
NDA
Marketing start
2014-04-14
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
4.28 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HEMANGEOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE4.28 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui1495058, 1495064

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64370-375-012023-04-07C16284748780-1f386c649-f02a-0266-e053-dadaa90a7c1aHEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-502023-04-07C16284748780-1f386c649-f02a-0266-e053-dadaa90a7c1aHEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-012023-01-30C16284748780-1f386c649-f02a-0266-e053-dadaa90a7c1aHEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-502023-01-30C16284748780-1f386c649-f02a-0266-e053-dadaa90a7c1aHEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64370-375-01HEMANGEOL1 in 1 CARTONSOLUTION120
64370-375-01HEMANGEOL120 mL in 1 BOTTLE, GLASSSOLUTION12020
64370-375-50HEMANGEOL50 mL in 1 BOTTLE, GLASSSOLUTION5020
64370-375-50HEMANGEOL1 in 1 CARTONSOLUTION120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64370-375-01ML - Milliliter64370-37579299d85-bb2a-4d6f-849b-0fa9dae6998e12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VHEMANGEOL (PROPRANOLOL HYDROCHLORIDE) SOLUTION [PIERRE FABRE PHARMACEUTICALS, INC.]9
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQHEMANGEOL (PROPRANOLOL HYDROCHLORIDE) SOLUTION [PIERRE FABRE PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64370-375HEMANGEOL (PROPRANOLOL HYDROCHLORIDE) SOLUTION [PIERRE FABRE PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 4 package rows20241108_b6f9dd2a-632b-87eb-70f0-b2064d7ed48a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1495064Hemangeol 4.28 MG in 1 mL Oral SolutionPSNb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20
1495058propranolol HCl 4.28 MG in 1 mL Oral SolutionPSNb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20
1495064propranolol hydrochloride 4.28 MG/ML Oral Solution [Hemangeol]SBDb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20
1495058propranolol hydrochloride 4.28 MG/ML Oral SolutionSCDb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20
1495064Hemangeol 4.28 MG per 1 ML Oral SolutionSYb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20
1495064Hemangeol 4.28 MG/ML (as propranolol 3.75 MG/ML) Oral SolutionSYb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20
1495058propranolol HCl 4.28 MG/ML (as propranolol 3.75 MG/ML) Oral SolutionSYb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20
1495058propranolol hydrochloride 4.28 MG per 1 ML Oral SolutionSYb6f9dd2a-632b-87eb-70f0-b2064d7ed48a20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64370-375-01643700375011 BOTTLE, GLASS in 1 CARTON (64370-375-01) / 120 mL in 1 BOTTLE, GLASS2014-04-140000-00-00NoNoCurrent
64370-375-50643700375501 BOTTLE, GLASS in 1 CARTON (64370-375-50) / 50 mL in 1 BOTTLE, GLASS2014-04-140000-00-00NoNoCurrent