FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
50090-4651
11-digit product format
500904651
Labeler code
50090
Product ID
50090-4651_5e478d12-c656-456d-8248-58cb7a1d7f73
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4651-02023-02-07C16284748780-1f386c649-a62c-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4651-02023-01-30C16284748780-1f386c649-a62c-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4651-0Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED408
50090-4651-1Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED288

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4651-0EA - Each50090-46516184ec34-11a1-42d7-a9af-2171fe804f4c12022-12-07
50090-4651-1EA - Each50090-4651a5acc0b5-60aa-42b2-94ef-3e751d02a5d712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4651PENICILLIN V POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20231115_58badf2b-0fb7-4d56-9f47-18b2fdda5199.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN58badf2b-0fb7-4d56-9f47-18b2fdda51998
834102penicillin V potassium 500 MG Oral TabletSCD58badf2b-0fb7-4d56-9f47-18b2fdda51998
834102Penicillin V K+ 500 MG Oral TabletSY58badf2b-0fb7-4d56-9f47-18b2fdda51998
834102Penicillin V Pot 500 MG Oral TabletSY58badf2b-0fb7-4d56-9f47-18b2fdda51998

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4651-05009046510040 TABLET, FILM COATED in 1 BOTTLE (50090-4651-0) 2019-10-250000-00-00NoNoCurrent
50090-4651-15009046510128 TABLET, FILM COATED in 1 BOTTLE (50090-4651-1) 2023-10-31NoNoCurrent