FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
10544-297
11-digit product format
105440297
Labeler code
10544
Product ID
10544-297_10694145-3d30-1fbf-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA062935
Marketing category
ANDA
Marketing start
2009-12-29
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
2017-12-31
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
10544-297-202020-01-31C16284748780-19d75b9d0-02aa-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP - 250 mg and 500 mg PENICILLIN V POTASSIUM- penicillin v potassium for solution R x Only
10544-297-282020-01-31C16284748780-19d75b9d0-02aa-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP - 250 mg and 500 mg PENICILLIN V POTASSIUM- penicillin v potassium for solution R x Only
10544-297-302020-01-31C16284748780-19d75b9d0-02aa-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP - 250 mg and 500 mg PENICILLIN V POTASSIUM- penicillin v potassium for solution R x Only
10544-297-402020-01-31C16284748780-19d75b9d0-02aa-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP - 250 mg and 500 mg PENICILLIN V POTASSIUM- penicillin v potassium for solution R x Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-297-20Penicillin V Potassium20 in 1 BOTTLETABLET204
10544-297-28Penicillin V Potassium28 in 1 BOTTLETABLET284
10544-297-30Penicillin V Potassium30 in 1 BOTTLETABLET304
10544-297-40Penicillin V Potassium40 in 1 BOTTLETABLET404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-297-20EA - Each10544-2971f591aab-b006-4e71-b5bb-cf8974bc913212015-10-02
10544-297-28EA - Each10544-297b964fda3-eb47-41ca-afd9-9c36c8970f7812015-10-02
10544-297-30EA - Each10544-29725aff5f8-a884-43d3-b334-ef0c3143805412014-07-02
10544-297-40EA - Each10544-2970c44b4d4-5c90-482f-ad0c-a5afd02d6f2812014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN V POTASSIUMACTIVE INGREDIENT146T0TU1JBPENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4
PENICILLIN VACTIVE MOIETYZ61I075U2WPENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-297PENICILLIN V POTASSIUM TABLET [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 4 package rows20150304_30b88469-9074-4d60-bd95-9f6a4078e3b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN30b88469-9074-4d60-bd95-9f6a4078e3b44
834102penicillin V potassium 500 MG Oral TabletPSN30b88469-9074-4d60-bd95-9f6a4078e3b44
834061penicillin V potassium 250 MG Oral TabletSCD30b88469-9074-4d60-bd95-9f6a4078e3b44
834102penicillin V potassium 500 MG Oral TabletSCD30b88469-9074-4d60-bd95-9f6a4078e3b44
834061Penicillin V K+ 250 MG Oral TabletSY30b88469-9074-4d60-bd95-9f6a4078e3b44
834102Penicillin V K+ 500 MG Oral TabletSY30b88469-9074-4d60-bd95-9f6a4078e3b44
834061Penicillin V Pot 250 MG Oral TabletSY30b88469-9074-4d60-bd95-9f6a4078e3b44
834102Penicillin V Pot 500 MG Oral TabletSY30b88469-9074-4d60-bd95-9f6a4078e3b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-297-201054402972020 in 1 BOTTLEHistorical
10544-297-281054402972828 in 1 BOTTLEHistorical
10544-297-301054402973030 in 1 BOTTLEHistorical
10544-297-401054402974040 in 1 BOTTLEHistorical