FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71335-0955
11-digit product format
713350955
Labeler code
71335
Product ID
71335-0955_5b7d1148-a500-43c2-aefd-b8ac3aa2e6bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070221
Marketing category
ANDA
Marketing start
2010-06-21
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 mg/1
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
Propranolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448, 856457, 856519, 856578

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
71335-0955-1Propranolol Hydrochloride30 in 1 BOTTLETABLET3022
71335-0955-2Propranolol Hydrochloride100 in 1 BOTTLETABLET10022
71335-0955-3Propranolol Hydrochloride90 in 1 BOTTLETABLET9022
71335-0955-4Propranolol Hydrochloride60 in 1 BOTTLETABLET6022
71335-0955-5Propranolol Hydrochloride10 in 1 BOTTLETABLET1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0955-3EA - Each71335-0955e34990c4-be6b-46e0-be66-071374d7f74212020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0955PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]22Current NDC, Legacy NDC, 5 package rows20241211_360de855-b8be-409f-9ca6-d0a0368af174.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856457propranolol HCl 20 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856519propranolol HCl 40 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856578propranolol HCl 80 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856448propranolol hydrochloride 10 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422
856457propranolol hydrochloride 20 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422
856519propranolol hydrochloride 40 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422
856578propranolol hydrochloride 80 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0955-17133509550130 TABLET in 1 BOTTLE (71335-0955-1) 30 tablet2018-09-240000-00-00NoNoCurrent
71335-0955-271335095502100 TABLET in 1 BOTTLE (71335-0955-2) 100 tablet2018-09-240000-00-00NoNoCurrent
71335-0955-37133509550390 TABLET in 1 BOTTLE (71335-0955-3) 90 tablet2018-09-240000-00-00NoNoCurrent
71335-0955-47133509550460 TABLET in 1 BOTTLE (71335-0955-4) 60 tablet2018-09-240000-00-00NoNoCurrent
71335-0955-57133509550510 TABLET in 1 BOTTLE (71335-0955-5) 10 tablet2018-09-240000-00-00NoNoCurrent