FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71335-3097
11-digit product format
713353097
Labeler code
71335
Product ID
71335-3097_ab500871-9978-4576-b788-6501be241836
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
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856457

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
71335-3097-1Propranolol Hydrochloride20 in 1 BOTTLETABLET201
71335-3097-2Propranolol Hydrochloride30 in 1 BOTTLETABLET301
71335-3097-3Propranolol Hydrochloride100 in 1 BOTTLETABLET1001
71335-3097-4Propranolol Hydrochloride60 in 1 BOTTLETABLET601
71335-3097-5Propranolol Hydrochloride90 in 1 BOTTLETABLET901
71335-3097-6Propranolol Hydrochloride180 in 1 BOTTLETABLET1801
71335-3097-7Propranolol Hydrochloride28 in 1 BOTTLETABLET281
71335-3097-8Propranolol Hydrochloride10 in 1 BOTTLETABLET101
71335-3097-9Propranolol Hydrochloride120 in 1 BOTTLETABLET1201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSN8f31a40c-7c79-457b-af6e-d945e4807cff1
856457propranolol hydrochloride 20 MG Oral TabletSCD8f31a40c-7c79-457b-af6e-d945e4807cff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3097-17133530970120 TABLET in 1 BOTTLE (71335-3097-1) 20 tablet2026-03-13NoNoHistorical
71335-3097-27133530970230 TABLET in 1 BOTTLE (71335-3097-2) 30 tablet2026-03-13NoNoHistorical
71335-3097-371335309703100 TABLET in 1 BOTTLE (71335-3097-3) 100 tablet2026-03-13NoNoHistorical
71335-3097-47133530970460 TABLET in 1 BOTTLE (71335-3097-4) 60 tablet2026-03-13NoNoHistorical
71335-3097-57133530970590 TABLET in 1 BOTTLE (71335-3097-5) 90 tablet2026-03-13NoNoHistorical
71335-3097-671335309706180 TABLET in 1 BOTTLE (71335-3097-6) 180 tablet2026-03-13NoNoHistorical
71335-3097-77133530970728 TABLET in 1 BOTTLE (71335-3097-7) 28 tablet2026-03-13NoNoHistorical
71335-3097-87133530970810 TABLET in 1 BOTTLE (71335-3097-8) 10 tablet2026-03-13NoNoHistorical
71335-3097-971335309709120 TABLET in 1 BOTTLE (71335-3097-9) 120 tablet2026-03-13NoNoHistorical