FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
51655-864
11-digit product format
516550864
Labeler code
51655
Product ID
51655-864_4973eb8e-598f-13ad-e063-6394a90a8b68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA071972
Marketing category
ANDA
Marketing start
2023-02-13
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-864-26Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903
51655-864-52Propranolol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-864PROPRANOLOL HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230921_f76b7edc-6d7d-9cba-e053-6294a90a035c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNf76b7edc-6d7d-9cba-e053-6294a90a035c3
856448propranolol hydrochloride 10 MG Oral TabletSCDf76b7edc-6d7d-9cba-e053-6294a90a035c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-864-265165508642690 TABLET in 1 BOTTLE, PLASTIC (51655-864-26) 90 tablet2023-02-13NoNoHistorical
51655-864-525165508645230 TABLET in 1 BOTTLE, PLASTIC (51655-864-52) 30 tablet2023-09-08NoNoHistorical