FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
50090-7104
11-digit product format
500907104
Labeler code
50090
Product ID
50090-7104_1d38c2d9-7c4a-4449-b0d5-55131d43f3cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071972
Marketing category
ANDA
Marketing start
2021-06-03
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
50090-7104-1Propranolol Hydrochloride60 in 1 BOTTLETABLET603
50090-7104-6Propranolol Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7104-1EA - Each50090-71047072905f-3155-42d8-8b3a-8a386f21c14512024-04-05
50090-7104-6EA - Each50090-710474a939fd-849c-49d5-9077-7997838df90012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7104PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20240307_7b751df5-0751-435b-8755-3d50476cabd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856519propranolol HCl 40 MG Oral TabletPSN7b751df5-0751-435b-8755-3d50476cabd23
856519propranolol hydrochloride 40 MG Oral TabletSCD7b751df5-0751-435b-8755-3d50476cabd23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7104-15009071040160 TABLET in 1 BOTTLE (50090-7104-1) 60 tablet2024-02-29NoNoCurrent
50090-7104-65009071040690 TABLET in 1 BOTTLE (50090-7104-6) 90 tablet2024-02-29NoNoCurrent