FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
50090-4652
11-digit product format
500904652
Labeler code
50090
Product ID
50090-4652_91634054-22e7-4ac6-9c61-a443a41a390c
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
50090-4652-12023-02-07C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-22023-02-07C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-42023-02-07C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-52023-02-07C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-62023-02-07C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-12023-01-30C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-22023-01-30C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-42023-01-30C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-52023-01-30C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-4652-62023-01-30C16284748780-1f386c649-a627-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4652-1Penicillin V Potassium12 in 1 BOTTLETABLET, FILM COATED128
50090-4652-2Penicillin V Potassium20 in 1 BOTTLETABLET, FILM COATED208
50090-4652-4Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED288
50090-4652-5Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED308
50090-4652-6Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4652-1EA - Each50090-46521d1a9394-a921-42b9-84d8-46c32e50ed8212024-08-12
50090-4652-2EA - Each50090-4652c146693e-e181-4bf0-8283-97bc5b2c004612024-09-09
50090-4652-4EA - Each50090-465281e5aabf-954e-4f94-b351-b994bd53f2a012022-12-07
50090-4652-5EA - Each50090-46527955d109-d46e-45d6-9268-5b5aae03d9fc12022-12-07
50090-4652-6EA - Each50090-46521e3b44b9-9126-4677-8ca3-1aab57feab2112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4652PENICILLIN V POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 5 package rows20240731_887a719a-4e5f-4e04-9935-7ad7ce75cabe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN887a719a-4e5f-4e04-9935-7ad7ce75cabe8
834102penicillin V potassium 500 MG Oral TabletSCD887a719a-4e5f-4e04-9935-7ad7ce75cabe8
834102Penicillin V K+ 500 MG Oral TabletSY887a719a-4e5f-4e04-9935-7ad7ce75cabe8
834102Penicillin V Pot 500 MG Oral TabletSY887a719a-4e5f-4e04-9935-7ad7ce75cabe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4652-15009046520112 TABLET, FILM COATED in 1 BOTTLE (50090-4652-1) 2019-10-250000-00-00NoNoCurrent
50090-4652-25009046520220 TABLET, FILM COATED in 1 BOTTLE (50090-4652-2) 2019-10-250000-00-00NoNoCurrent
50090-4652-45009046520428 TABLET, FILM COATED in 1 BOTTLE (50090-4652-4) 2019-10-250000-00-00NoNoCurrent
50090-4652-55009046520530 TABLET, FILM COATED in 1 BOTTLE (50090-4652-5) 2019-10-250000-00-00NoNoCurrent
50090-4652-65009046520640 TABLET, FILM COATED in 1 BOTTLE (50090-4652-6) 2019-10-250000-00-00NoNoCurrent