FDA.reportPublic FDA data

PROPRANOLOL HYDROCHLORIDE

Product NDC
72189-322
11-digit product format
721890322
Labeler code
72189
Product ID
72189-322_2c3d2dfe-1000-b986-e063-6294a90a84c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPRANOLOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA070322
Marketing category
ANDA
Marketing start
2022-02-11
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
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 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
72189-322-30PROPRANOLOL HYDROCHLORIDE30 in 1 BOTTLETABLET306
72189-322-60PROPRANOLOL HYDROCHLORIDE60 in 1 BOTTLETABLET606
72189-322-90PROPRANOLOL HYDROCHLORIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-322-30EA - Each72189-3225fbe039c-5d42-484e-afb4-6d57d3cb42bc12022-03-09
72189-322-60EA - Each72189-322a522b5d3-2d94-49d6-907d-83334a9abc3612022-07-06
72189-322-90EA - Each72189-322e07d9621-84c1-4ccb-8d3c-f5070f237e8012022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-322PROPRANOLOL HYDROCHLORIDE TABLET [DIRECT RX]6Current NDC, Legacy NDC, 3 package rows20250122_d7c0cc12-6d2d-7146-e053-2995a90a85a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNd7c0cc12-6d2d-7146-e053-2995a90a85a46
856448propranolol hydrochloride 10 MG Oral TabletSCDd7c0cc12-6d2d-7146-e053-2995a90a85a46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-322-307218903223030 TABLET in 1 BOTTLE (72189-322-30) 30 tablet2022-02-110000-00-00NoNoCurrent
72189-322-607218903226060 TABLET in 1 BOTTLE (72189-322-60) 60 tablet2022-02-110000-00-00NoNoCurrent
72189-322-907218903229090 TABLET in 1 BOTTLE (72189-322-90) 90 tablet2022-02-110000-00-00NoNoCurrent