FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71205-794
11-digit product format
712050794
Labeler code
71205
Product ID
71205-794_91055555-6967-4b6a-b5c8-5211ec18d2c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA070322
Marketing category
ANDA
Marketing start
2019-10-31
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
71205-794-30Propranolol Hydrochloride30 in 1 BOTTLETABLET301
71205-794-60Propranolol Hydrochloride60 in 1 BOTTLETABLET601
71205-794-90Propranolol Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-794PROPRANOLOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20230422_91055555-6967-4b6a-b5c8-5211ec18d2c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856519propranolol HCl 40 MG Oral TabletPSN91055555-6967-4b6a-b5c8-5211ec18d2c81
856519propranolol hydrochloride 40 MG Oral TabletSCD91055555-6967-4b6a-b5c8-5211ec18d2c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-794-307120507943030 TABLET in 1 BOTTLE (71205-794-30) 30 tablet2023-04-20NoNoCurrent
71205-794-607120507946060 TABLET in 1 BOTTLE (71205-794-60) 60 tablet2023-04-20NoNoCurrent
71205-794-907120507949090 TABLET in 1 BOTTLE (71205-794-90) 90 tablet2023-04-20NoNoCurrent