FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71335-3117
11-digit product format
713353117
Labeler code
71335
Product ID
71335-3117_501fbf8d-8607-4b01-b92b-a70d23e71259
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078955
Marketing category
ANDA
Marketing start
2024-09-19
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
71335-3117-1Propranolol Hydrochloride30 in 1 BOTTLETABLET301
71335-3117-2Propranolol Hydrochloride60 in 1 BOTTLETABLET601
71335-3117-3Propranolol Hydrochloride100 in 1 BOTTLETABLET1001
71335-3117-4Propranolol Hydrochloride90 in 1 BOTTLETABLET901
71335-3117-5Propranolol Hydrochloride120 in 1 BOTTLETABLET1201
71335-3117-6Propranolol Hydrochloride10 in 1 BOTTLETABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNf70e5e97-a045-4d22-8da5-be4b7eb775301
856448propranolol hydrochloride 10 MG Oral TabletSCDf70e5e97-a045-4d22-8da5-be4b7eb775301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3117-17133531170130 TABLET in 1 BOTTLE (71335-3117-1) 30 tablet2026-03-30NoNoHistorical
71335-3117-27133531170260 TABLET in 1 BOTTLE (71335-3117-2) 60 tablet2026-03-30NoNoHistorical
71335-3117-371335311703100 TABLET in 1 BOTTLE (71335-3117-3) 100 tablet2026-03-30NoNoHistorical
71335-3117-47133531170490 TABLET in 1 BOTTLE (71335-3117-4) 90 tablet2026-03-30NoNoHistorical
71335-3117-571335311705120 TABLET in 1 BOTTLE (71335-3117-5) 120 tablet2026-03-30NoNoHistorical
71335-3117-67133531170610 TABLET in 1 BOTTLE (71335-3117-6) 10 tablet2026-03-30NoNoHistorical