FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
68071-4838
11-digit product format
680714838
Labeler code
68071
Product ID
68071-4838_1ae17471-a0b0-8691-e063-6394a90aa28a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-4838-82021-02-17C16284748780-1ba0f9c33-43e0-a910-e053-dadaa90a0b85Penicillin V Potassium Tablets, USP Rx only
68071-4838-82021-01-29C16284748780-1ba0f9c33-43e0-a910-e053-dadaa90a0b85Penicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4838-3Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED304
68071-4838-8Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4838PENICILLIN V POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240616_861ccfaa-8b7a-0def-e053-2991aa0a1a39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN861ccfaa-8b7a-0def-e053-2991aa0a1a394
834102penicillin V potassium 500 MG Oral TabletSCD861ccfaa-8b7a-0def-e053-2991aa0a1a394
834102Penicillin V K+ 500 MG Oral TabletSY861ccfaa-8b7a-0def-e053-2991aa0a1a394
834102Penicillin V Pot 500 MG Oral TabletSY861ccfaa-8b7a-0def-e053-2991aa0a1a394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4838-36807148380330 TABLET, FILM COATED in 1 BOTTLE (68071-4838-3) 2019-04-090000-00-00NoNoCurrent
68071-4838-86807148380828 TABLET, FILM COATED in 1 BOTTLE (68071-4838-8) 2019-04-090000-00-00NoNoCurrent