FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
50090-3506
11-digit product format
500903506
Labeler code
50090
Product ID
50090-3506_21100bad-907a-4278-a3fa-d7c1e7275002
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
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3506-22024-02-22C16284748780-1f386c649-f6c6-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only
50090-3506-22023-01-30C16284748780-1f386c649-f6c6-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3506-0Penicillin V Potassium20 in 1 BOTTLETABLET, FILM COATED204
50090-3506-2Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED284
50090-3506-3Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED304
50090-3506-4Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3506-0EA - Each50090-3506b11fa047-1d33-4a84-826d-d381cec1f7e812024-03-12
50090-3506-2EA - Each50090-3506063a4296-7b41-474a-8fe7-5433122e67e412024-03-12
50090-3506-3EA - Each50090-3506c6372cd1-2a1a-4d2e-a541-4d3f456d954612024-03-12
50090-3506-4EA - Each50090-35060b1e0b77-e460-4080-b329-e171530a645a12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3506PENICILLIN V POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 4 package rows20240224_9532c961-2dd6-4e8a-a345-86d57a21c4a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN9532c961-2dd6-4e8a-a345-86d57a21c4a34
834061penicillin V potassium 250 MG Oral TabletSCD9532c961-2dd6-4e8a-a345-86d57a21c4a34
834061Penicillin V K+ 250 MG Oral TabletSY9532c961-2dd6-4e8a-a345-86d57a21c4a34
834061Penicillin V Pot 250 MG Oral TabletSY9532c961-2dd6-4e8a-a345-86d57a21c4a34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3506-05009035060020 TABLET, FILM COATED in 1 BOTTLE (50090-3506-0) 2018-10-08NoNoCurrent
50090-3506-25009035060228 TABLET, FILM COATED in 1 BOTTLE (50090-3506-2) 2018-07-180000-00-00NoNoCurrent
50090-3506-35009035060330 TABLET, FILM COATED in 1 BOTTLE (50090-3506-3) 2024-02-16NoNoCurrent
50090-3506-45009035060440 TABLET, FILM COATED in 1 BOTTLE (50090-3506-4) 2024-02-16NoNoCurrent