FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
70518-3466
11-digit product format
705183466
Labeler code
70518
Product ID
70518-3466_512691c1-c728-ac5d-e063-6294a90aa411
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071972
Marketing category
ANDA
Marketing start
2022-08-03
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
70518-3466-0Propranolol Hydrochloride100 in 1 BOXTABLET1009
70518-3466-1Propranolol Hydrochloride1 in 1 POUCHTABLET19
70518-3466-2Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET309
70518-3466-3Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3466PROPRANOLOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 4 package rows20241006_a3bd3ef9-539d-450e-900b-95be0e46095b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSNa3bd3ef9-539d-450e-900b-95be0e46095b9
856457propranolol hydrochloride 20 MG Oral TabletSCDa3bd3ef9-539d-450e-900b-95be0e46095b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3466-070518346600100 POUCH in 1 BOX (70518-3466-0) > 1 TABLET in 1 POUCH (70518-3466-1) 100 pouch2022-08-030000-00-00NoNoCurrent
70518-3466-1705183466011 in 1 POUCHHistorical
70518-3466-27051834660230 TABLET in 1 BLISTER PACK (70518-3466-2) 30 tablet2022-10-240000-00-00NoNoCurrent
70518-3466-37051834660330 TABLET in 1 BLISTER PACK (70518-3466-3) 30 tablet2024-01-31NoNoHistorical