FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
70518-3102
11-digit product format
705183102
Labeler code
70518
Product ID
70518-3102_50101b30-7cfd-7813-e063-6394a90a4a2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA070322
Marketing category
ANDA
Marketing start
2021-05-26
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
70518-3102-0Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET3012
70518-3102-1Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET3012
70518-3102-2Propranolol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3012
70518-3102-3Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9012
70518-3102-4Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3102PROPRANOLOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20250418_07c3fcab-33fe-4a6a-ba67-2d042190c146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN07c3fcab-33fe-4a6a-ba67-2d042190c14612
856448propranolol hydrochloride 10 MG Oral TabletSCD07c3fcab-33fe-4a6a-ba67-2d042190c14612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3102-07051831020030 TABLET in 1 BLISTER PACK (70518-3102-0) 30 tablet2021-05-260000-00-00NoNoCurrent
70518-3102-17051831020130 TABLET in 1 BLISTER PACK (70518-3102-1) 30 tablet2022-08-250000-00-00NoNoCurrent
70518-3102-27051831020230 in 1 BOTTLE, PLASTICHistorical
70518-3102-37051831020390 in 1 BOTTLE, PLASTICHistorical
70518-3102-47051831020490 TABLET in 1 BOTTLE, PLASTIC (70518-3102-4) 90 tablet2025-04-16NoNoCurrent