FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
50090-3425
11-digit product format
500903425
Labeler code
50090
Product ID
50090-3425_97675890-766d-4b6e-8427-67602c155248
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
250 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 POTASSIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii146T0TU1JB
Rxcui834061

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3425-02024-02-20C16284748780-1f386c64a-1ac2-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-3425-02023-01-30C16284748780-1f386c64a-1ac2-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3425-0Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED404
50090-3425-1Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3425-0EA - Each50090-3425f8ba3b0a-2ef7-46d4-b880-434e25d25f0b12019-06-19
50090-3425-1EA - Each50090-3425c307937d-3976-447f-9b55-45c6a686181012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3425PENICILLIN V POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20240221_198c4df5-b4ab-49e1-996b-c60f780238bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN198c4df5-b4ab-49e1-996b-c60f780238bd4
834061penicillin V potassium 250 MG Oral TabletSCD198c4df5-b4ab-49e1-996b-c60f780238bd4
834061Penicillin V K+ 250 MG Oral TabletSY198c4df5-b4ab-49e1-996b-c60f780238bd4
834061Penicillin V Pot 250 MG Oral TabletSY198c4df5-b4ab-49e1-996b-c60f780238bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3425-05009034250040 TABLET, FILM COATED in 1 BOTTLE (50090-3425-0) 2018-03-300000-00-00NoNoCurrent
50090-3425-15009034250128 TABLET, FILM COATED in 1 BOTTLE (50090-3425-1) 2024-02-05NoNoCurrent