FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
50268-664
11-digit product format
502680664
Labeler code
50268
Product ID
50268-664_47fb48ff-0cf3-5853-e063-6294a90a82a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA071972
Marketing category
ANDA
Marketing start
2023-08-23
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448, 856457, 856519

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
50268-664-11Propranolol Hydrochloride1 in 1 BLISTER PACKTABLET12
50268-664-15Propranolol Hydrochloride50 in 1 BOXTABLET502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-664-11EA - Each50268-664ec570f59-b0b9-46b1-9329-38dc916ad45512023-09-05
50268-664-15EA - Each50268-6642369bfb3-6091-4b6b-bfba-c71d603a8b1012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-664PROPRANOLOL HYDROCHLORIDE TABLET [AVPAK]1Current NDC, 2 package rows20230824_039b415b-094a-da37-e063-6294a90a52d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN039b415b-094a-da37-e063-6294a90a52d72
856457propranolol HCl 20 MG Oral TabletPSN039b415b-094a-da37-e063-6294a90a52d72
856519propranolol HCl 40 MG Oral TabletPSN039b415b-094a-da37-e063-6294a90a52d72
856448propranolol hydrochloride 10 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856457propranolol hydrochloride 20 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856519propranolol hydrochloride 40 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-664-11502680664111 in 1 BLISTER PACKHistorical
50268-664-155026806641550 BLISTER PACK in 1 BOX (50268-664-15) / 1 TABLET in 1 BLISTER PACK (50268-664-11) 50 blister pack2023-08-23NoNoHistorical