FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
51655-228
11-digit product format
516550228
Labeler code
51655
Product ID
51655-228_48d2bc44-7fbf-c8d1-e063-6294a90a7c42
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
2022-08-19
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856519

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
51655-228-25Propranolol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET603
51655-228-26Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903
51655-228-52Propranolol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-228PROPRANOLOL HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 3 package rows20230413_f2b68e23-2a9d-76b4-e053-2995a90a375a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856519propranolol HCl 40 MG Oral TabletPSNf2b68e23-2a9d-76b4-e053-2995a90a375a3
856519propranolol hydrochloride 40 MG Oral TabletSCDf2b68e23-2a9d-76b4-e053-2995a90a375a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-228-255165502282560 TABLET in 1 BOTTLE, PLASTIC (51655-228-25) 60 tablet2023-03-28NoNoCurrent
51655-228-265165502282690 TABLET in 1 BOTTLE, PLASTIC (51655-228-26) 90 tablet2022-08-19NoNoCurrent
51655-228-525165502285230 TABLET in 1 BOTTLE, PLASTIC (51655-228-52) 30 tablet2022-10-27NoNoCurrent