FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
43063-647
11-digit product format
430630647
Labeler code
43063
Product ID
43063-647_2f3b1710-4cbb-8df1-e063-6294a90a7539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA070221
Marketing category
ANDA
Marketing start
2010-06-21
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
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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856519

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
43063-647-30Propranolol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3022
43063-647-90Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-647-30EA - Each43063-6478f96a6f0-b152-4805-8177-b0408982aae212016-03-04
43063-647-90EA - Each43063-647e606fac6-c493-4777-be49-91a0bf33dd8512016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-647PROPRANOLOL HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 2 package rows20250418_29a3a271-dabc-437f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856519propranolol HCl 40 MG Oral TabletPSN29a3a271-dabc-437f-e054-00144ff8d46c22
856519propranolol hydrochloride 40 MG Oral TabletSCD29a3a271-dabc-437f-e054-00144ff8d46c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-647-304306306473030 TABLET in 1 BOTTLE, PLASTIC (43063-647-30) 30 tablet2016-03-090000-00-00NoNoCurrent
43063-647-904306306479090 TABLET in 1 BOTTLE, PLASTIC (43063-647-90) 90 tablet2016-03-090000-00-00NoNoCurrent