FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
76420-383
11-digit product format
764200383
Labeler code
76420
Product ID
76420-383_366b6b94-8ad2-8ec9-e063-6394a90a813b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA070322
Marketing category
ANDA
Marketing start
2019-10-31
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
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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448, 856457, 856519, 856556, 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
76420-383-00Propranolol Hydrochloride1000 in 1 BOTTLETABLET10001
76420-383-01Propranolol Hydrochloride100 in 1 BOTTLETABLET1001
76420-383-20Propranolol Hydrochloride20 in 1 BOTTLETABLET201
76420-383-30Propranolol Hydrochloride30 in 1 BOTTLETABLET301
76420-383-60Propranolol Hydrochloride60 in 1 BOTTLETABLET601
76420-383-90Propranolol Hydrochloride90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856457propranolol HCl 20 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856519propranolol HCl 40 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856556propranolol HCl 60 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856578propranolol HCl 80 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856448propranolol hydrochloride 10 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856457propranolol hydrochloride 20 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856519propranolol hydrochloride 40 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856556propranolol hydrochloride 60 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856578propranolol hydrochloride 80 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-383-00764200383001000 TABLET in 1 BOTTLE (76420-383-00) 1000 tablet2025-05-31NoNoHistorical
76420-383-0176420038301100 TABLET in 1 BOTTLE (76420-383-01) 100 tablet2025-05-31NoNoHistorical
76420-383-207642003832020 TABLET in 1 BOTTLE (76420-383-20) 20 tablet2025-05-31NoNoHistorical
76420-383-307642003833030 TABLET in 1 BOTTLE (76420-383-30) 30 tablet2025-05-31NoNoHistorical
76420-383-607642003836060 TABLET in 1 BOTTLE (76420-383-60) 60 tablet2025-05-31NoNoHistorical
76420-383-907642003839090 TABLET in 1 BOTTLE (76420-383-90) 90 tablet2025-05-31NoNoHistorical