FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
50090-5543
11-digit product format
500905543
Labeler code
50090
Product ID
50090-5543_9a43c172-e359-48f7-813d-1ba3c70a522e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065435
Marketing category
ANDA
Marketing start
2008-04-29
Substance
PENICILLIN V POTASSIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Penicillin V Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN V POTASSIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii146T0TU1JB
Rxcui834102

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5543-0Penicillin V Potassium6 in 1 BOTTLETABLET, FILM COATED65
50090-5543-1Penicillin V Potassium12 in 1 BOTTLETABLET, FILM COATED125
50090-5543-2Penicillin V Potassium20 in 1 BOTTLETABLET, FILM COATED205
50090-5543-4Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED285
50090-5543-5Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED305
50090-5543-6Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5543-1EA - Each50090-55438b2a2000-e360-4147-92a7-c6d0e15ca90c12023-02-06
50090-5543-2EA - Each50090-554355756ec9-b587-4a20-b796-f95abd16297112023-10-16
50090-5543-4EA - Each50090-5543a1672ed2-2b2a-470d-8724-da066b6cd60812023-10-16
50090-5543-5EA - Each50090-5543ae6627bb-3911-496d-aa67-eaf8fdd89de312023-10-16
50090-5543-6EA - Each50090-5543d10c27d7-0c70-4a52-94c2-d3258492027d12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5543PENICILLIN V POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 6 package rows20230918_efdda3a5-77d9-4c66-9da7-2be3f3981b79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSNefdda3a5-77d9-4c66-9da7-2be3f3981b795
834102penicillin V potassium 500 MG Oral TabletSCDefdda3a5-77d9-4c66-9da7-2be3f3981b795
834102Penicillin V K+ 500 MG Oral TabletSYefdda3a5-77d9-4c66-9da7-2be3f3981b795
834102Penicillin V Pot 500 MG Oral TabletSYefdda3a5-77d9-4c66-9da7-2be3f3981b795

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5543-0500905543006 TABLET, FILM COATED in 1 BOTTLE (50090-5543-0) 2021-05-140000-00-00NoNoCurrent
50090-5543-15009055430112 TABLET, FILM COATED in 1 BOTTLE (50090-5543-1) 2021-05-140000-00-00NoNoCurrent
50090-5543-25009055430220 TABLET, FILM COATED in 1 BOTTLE (50090-5543-2) 2023-01-17NoNoHistorical
50090-5543-45009055430428 TABLET, FILM COATED in 1 BOTTLE (50090-5543-4) 2023-01-17NoNoHistorical
50090-5543-55009055430530 TABLET, FILM COATED in 1 BOTTLE (50090-5543-5) 2023-01-17NoNoHistorical
50090-5543-65009055430640 TABLET, FILM COATED in 1 BOTTLE (50090-5543-6) 2021-05-140000-00-00NoNoCurrent