FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
70518-3281
11-digit product format
705183281
Labeler code
70518
Product ID
70518-3281_509b58cd-c26d-36b4-e063-6294a90a8aad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071972
Marketing category
ANDA
Marketing start
2021-12-03
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
70518-3281-0Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET308
70518-3281-1Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET308
70518-3281-2Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3281PROPRANOLOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250210_1cd914b6-b250-4b11-8404-41db3589361e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN1cd914b6-b250-4b11-8404-41db3589361e8
856448propranolol hydrochloride 10 MG Oral TabletSCD1cd914b6-b250-4b11-8404-41db3589361e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3281-07051832810030 TABLET in 1 BLISTER PACK (70518-3281-0) 30 tablet2021-12-030000-00-00NoNoCurrent
70518-3281-17051832810130 TABLET in 1 BLISTER PACK (70518-3281-1) 30 tablet2025-02-07NoNoHistorical
70518-3281-27051832810290 TABLET in 1 BOTTLE, PLASTIC (70518-3281-2) 90 tablet2026-02-11NoNoHistorical