FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
0440-8056
11-digit product format
004408056
Labeler code
0440
Product ID
0440-8056_65771c7d-2af2-40bc-a504-0e4ee8affc07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA062935
Marketing category
ANDA
Marketing start
2004-02-01
Marketing end
0000-00-00
Substance
PENICILLIN V POTASSIUM
Active strength
500 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
0440-8056-402020-01-31C16284748780-19d75b9d0-05f8-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
0440-8056-40Penicillin 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
0440-8056PENICILLIN V POTASSIUM TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20131204_073feced-f57a-439a-9397-5e1493369b10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN073feced-f57a-439a-9397-5e1493369b101
834102penicillin V potassium 500 MG Oral TabletSCD073feced-f57a-439a-9397-5e1493369b101
834102Penicillin V K+ 500 MG Oral TabletSY073feced-f57a-439a-9397-5e1493369b101
834102Penicillin V Pot 500 MG Oral TabletSY073feced-f57a-439a-9397-5e1493369b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8056-400044080564040 in 1 BOTTLE, PLASTICHistorical