FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
83980-007
11-digit product format
839800007
Labeler code
83980
Product ID
83980-007_7854dd0a-2a35-4d7f-afe4-210b28966928
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ipca Laboratories Limited
Application
ANDA078955
Marketing category
ANDA
Marketing start
2024-09-19
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
Rxcui856448, 856457, 856519, 856556, 856578

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
83980-007-01Propranolol Hydrochloride100 in 1 BOTTLETABLET1003
83980-007-05Propranolol Hydrochloride500 in 1 BOTTLETABLET5003
83980-007-10Propranolol Hydrochloride1000 in 1 BOTTLETABLET10003
83980-007-13Propranolol Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83980-007-01EA - Each83980-007163d7727-00c1-4208-b7c0-965f9766436712024-10-04
83980-007-10EA - Each83980-0079e67c447-8040-464e-a260-704fb11a303e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83980-007PROPRANOLOL HYDROCHLORIDE TABLET [IPCA LABORATORIES LIMITED]1Current NDC, 4 package rows20240920_9288191e-4d07-4e37-ab66-7b9de9321cf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN9288191e-4d07-4e37-ab66-7b9de9321cf33
856457propranolol HCl 20 MG Oral TabletPSN9288191e-4d07-4e37-ab66-7b9de9321cf33
856519propranolol HCl 40 MG Oral TabletPSN9288191e-4d07-4e37-ab66-7b9de9321cf33
856556propranolol HCl 60 MG Oral TabletPSN9288191e-4d07-4e37-ab66-7b9de9321cf33
856578propranolol HCl 80 MG Oral TabletPSN9288191e-4d07-4e37-ab66-7b9de9321cf33
856448propranolol hydrochloride 10 MG Oral TabletSCD9288191e-4d07-4e37-ab66-7b9de9321cf33
856457propranolol hydrochloride 20 MG Oral TabletSCD9288191e-4d07-4e37-ab66-7b9de9321cf33
856519propranolol hydrochloride 40 MG Oral TabletSCD9288191e-4d07-4e37-ab66-7b9de9321cf33
856556propranolol hydrochloride 60 MG Oral TabletSCD9288191e-4d07-4e37-ab66-7b9de9321cf33
856578propranolol hydrochloride 80 MG Oral TabletSCD9288191e-4d07-4e37-ab66-7b9de9321cf33
856519propranolol HCl 40 MG Oral TabletPSNbe55cf2d-c2f8-4781-b2ef-fd607324265c2
856519propranolol hydrochloride 40 MG Oral TabletSCDbe55cf2d-c2f8-4781-b2ef-fd607324265c2
856519propranolol HCl 40 MG Oral TabletPSN4dd23053-0458-40f2-ac34-afb8cc9903aa1
856519propranolol hydrochloride 40 MG Oral TabletSCD4dd23053-0458-40f2-ac34-afb8cc9903aa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83980-007-0183980000701100 TABLET in 1 BOTTLE (83980-007-01) 100 tablet2024-09-19NoNoCurrent
83980-007-0583980000705500 TABLET in 1 BOTTLE (83980-007-05) 500 tablet2024-09-19NoNoCurrent
83980-007-10839800007101000 TABLET in 1 BOTTLE (83980-007-10) 1000 tablet2024-09-19NoNoCurrent
83980-007-138398000071330 TABLET in 1 BOTTLE (83980-007-13) 30 tablet2024-09-19NoNoCurrent