FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
53002-2010
11-digit product format
530022010
Labeler code
53002
Product ID
53002-2010_8d3bfb55-afe2-4ccb-bb84-2faf2fd705be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065435
Marketing category
ANDA
Marketing start
2008-04-29
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
No
Listing certified through
2021-12-31
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
53002-2010-12025-01-30C16284748780-19d75b9cf-e105-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP Rx only
53002-2010-12023-06-07C16284748780-19d75b9cf-e105-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP Rx only
53002-2010-12023-01-30C16284748780-19d75b9cf-e105-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP Rx only
53002-2010-12020-12-15C16284748780-19d75b9cf-e105-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP Rx only
53002-2010-12020-01-31C16284748780-19d75b9cf-e105-f424-e053-dadaa90a57cePenicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2010-1Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED4011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2010PENICILLIN V POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]11Legacy NDC, 1 package rows20230609_e6be30b5-30df-4652-a99c-6d4466b49063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSNe6be30b5-30df-4652-a99c-6d4466b4906311
834102penicillin V potassium 500 MG Oral TabletPSNe6be30b5-30df-4652-a99c-6d4466b4906311
834061penicillin V potassium 250 MG Oral TabletSCDe6be30b5-30df-4652-a99c-6d4466b4906311
834102penicillin V potassium 500 MG Oral TabletSCDe6be30b5-30df-4652-a99c-6d4466b4906311
834061Penicillin V K+ 250 MG Oral TabletSYe6be30b5-30df-4652-a99c-6d4466b4906311
834102Penicillin V K+ 500 MG Oral TabletSYe6be30b5-30df-4652-a99c-6d4466b4906311
834061Penicillin V Pot 250 MG Oral TabletSYe6be30b5-30df-4652-a99c-6d4466b4906311
834102Penicillin V Pot 500 MG Oral TabletSYe6be30b5-30df-4652-a99c-6d4466b4906311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2010-15300220100140 TABLET, FILM COATED in 1 BOTTLE (53002-2010-1) 2017-10-010000-00-00NoNoCurrent