FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
50090-7097
11-digit product format
500907097
Labeler code
50090
Product ID
50090-7097_57597f08-363f-431f-b18d-dba64a349d85
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
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
50090-7097-0Propranolol Hydrochloride40 in 1 BOTTLETABLET402
50090-7097-1Propranolol Hydrochloride100 in 1 BOTTLETABLET1002
50090-7097-5Propranolol Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7097-0EA - Each50090-7097f22e5937-092e-4ea5-82e2-c175dbf1571812024-03-12
50090-7097-1EA - Each50090-7097a5ef3776-fdaa-4f65-91ce-ba5312ad2ef712024-03-12
50090-7097-5EA - Each50090-709733e503f9-5ecb-4829-b657-bf9362e1352312024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7097PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20240229_d1110a10-a7f4-4295-9e94-8fbb56f77f67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNd1110a10-a7f4-4295-9e94-8fbb56f77f672
856448propranolol hydrochloride 10 MG Oral TabletSCDd1110a10-a7f4-4295-9e94-8fbb56f77f672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7097-05009070970040 TABLET in 1 BOTTLE (50090-7097-0) 40 tablet2024-02-22NoNoCurrent
50090-7097-150090709701100 TABLET in 1 BOTTLE (50090-7097-1) 100 tablet2024-02-27NoNoCurrent
50090-7097-55009070970590 TABLET in 1 BOTTLE (50090-7097-5) 90 tablet2024-02-27NoNoCurrent