FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
68071-4753
11-digit product format
680714753
Labeler code
68071
Product ID
68071-4753_1adb3623-ebcc-c05a-e063-6294a90acb6e
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
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
68071-4753-82021-02-17C16284748780-1ba0f9c33-3aaa-a910-e053-dadaa90a0b85Penicillin V Potassium Tablets, USP Rx only
68071-4753-82021-01-29C16284748780-1ba0f9c33-3aaa-a910-e053-dadaa90a0b85Penicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4753-6Penicillin V Potassium6 in 1 BOTTLETABLET, FILM COATED65
68071-4753-8Penicillin V Potassium8 in 1 BOTTLETABLET, FILM COATED85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4753PENICILLIN V POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20240616_813cc848-11ce-3af0-e053-2991aa0a326f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN813cc848-11ce-3af0-e053-2991aa0a326f5
834061penicillin V potassium 250 MG Oral TabletSCD813cc848-11ce-3af0-e053-2991aa0a326f5
834061Penicillin V K+ 250 MG Oral TabletSY813cc848-11ce-3af0-e053-2991aa0a326f5
834061Penicillin V Pot 250 MG Oral TabletSY813cc848-11ce-3af0-e053-2991aa0a326f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4753-6680714753066 TABLET, FILM COATED in 1 BOTTLE (68071-4753-6) 2019-02-060000-00-00NoNoCurrent
68071-4753-8680714753088 TABLET, FILM COATED in 1 BOTTLE (68071-4753-8) 2019-02-060000-00-00NoNoCurrent