FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
0440-8055
11-digit product format
004408055
Labeler code
0440
Product ID
0440-8055_dcd88916-a5bc-4735-badc-9b0d3cbff2ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA062936
Marketing category
ANDA
Marketing start
2004-02-01
Marketing end
0000-00-00
Substance
PENICILLIN V POTASSIUM
Active strength
250 mg/1
Pharmacologic classes
Penicillins [CS],Penicillin-class Antibacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
0440-8055-402020-01-31C16284748780-19d75b9cf-d9d3-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP - 250 mg and 500 mg Penicillin V Potassium for Oral Solution, USP - 125 mg/5 mL and 250 mg/5 mL R x Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-8055-40Penicillin V Potassium40 in 1 BOTTLE, PLASTICTABLET401

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN V POTASSIUMACTIVE INGREDIENT146T0TU1JBPENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1
PENICILLIN VACTIVE MOIETYZ61I075U2WPENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8055PENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20131204_1b98daa1-6c66-493a-a1f4-55508fee8a05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN1b98daa1-6c66-493a-a1f4-55508fee8a051
834061penicillin V potassium 250 MG Oral TabletSCD1b98daa1-6c66-493a-a1f4-55508fee8a051
834061Penicillin V K+ 250 MG Oral TabletSY1b98daa1-6c66-493a-a1f4-55508fee8a051
834061Penicillin V Pot 250 MG Oral TabletSY1b98daa1-6c66-493a-a1f4-55508fee8a051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8055-400044080554040 in 1 BOTTLE, PLASTICHistorical