Propranolol Hydrochloride

Product NDC
53002-4951
11-digit product format
530024951
Labeler code
53002
Product ID
53002-4951_265756b5-ba41-438a-9daf-6795a16770bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA070177
Marketing category
ANDA
Marketing start
1986-05-13
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4951-0Propranolol Hydrochloride100 in 1 BOTTLETABLET1003
53002-4951-3Propranolol Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4951PROPRANOLOL HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_7e1f3479-aeaf-419f-98fc-907cae064c61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856519propranolol HCl 40 MG Oral TabletPSN7e1f3479-aeaf-419f-98fc-907cae064c613
856519propranolol hydrochloride 40 MG Oral TabletSCD7e1f3479-aeaf-419f-98fc-907cae064c613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4951-053002495100100 TABLET in 1 BOTTLE (53002-4951-0) 100 tablet2020-01-010000-00-00NoNoCurrent
53002-4951-35300249510330 TABLET in 1 BOTTLE (53002-4951-3) 30 tablet2020-01-010000-00-00NoNoCurrent