FDA.reportPublic FDA data

PENICILLIN V POTASSIUM

Product NDC
61919-649
11-digit product format
619190649
Labeler code
61919
Product ID
61919-649_a87551af-c3c3-eee2-e053-2a95a90a96c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PENICILLIN V POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA065435
Marketing category
ANDA
Marketing start
2019-04-19
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
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
61919-649-282025-01-30C16284748780-12cef2736-ad6f-d83d-e063-dadaa90ab31fPENICILLIN V POTASSIUM
61919-649-302025-01-30C16284748780-12cef2736-77d3-d83d-e063-dadaa90ab31fPENICILLIN V POTASSIUM
61919-649-402025-01-30C16284748780-12cef2736-ad6f-d83d-e063-dadaa90ab31fPENICILLIN V POTASSIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-649-28PENICILLIN V POTASSIUM28 in 1 BOTTLETABLET, FILM COATED282
61919-649-40PENICILLIN V POTASSIUM40 in 1 BOTTLETABLET, FILM COATED402
61919-649-30PENICILLIN V POTASSIUM30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-649-28EA - Each61919-6498e59ab16-f874-49fe-a6ce-cd1ad1af92a312019-05-02
61919-649-30EA - Each61919-649dd113523-b2d8-47da-8458-f98575f6740212019-11-12
61919-649-40EA - Each61919-649b1afa67f-a168-488d-a651-067c2009613712020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-649PENICILLIN V POTASSIUM TABLET, FILM COATED [DIRECTRX]2Legacy NDC, 2 package rows20200620_86e6f050-92c9-7b28-e053-2991aa0a9754.zip
61919-649PENICILLIN V POTASSIUM TABLET, FILM COATED [DIRECT_RX]1Legacy NDC, 1 package rows20191009_946783a7-500d-84d5-e053-2995a90a13f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN86e6f050-92c9-7b28-e053-2991aa0a97542
834102penicillin V potassium 500 MG Oral TabletSCD86e6f050-92c9-7b28-e053-2991aa0a97542
834102Penicillin V K+ 500 MG Oral TabletSY86e6f050-92c9-7b28-e053-2991aa0a97542
834102Penicillin V Pot 500 MG Oral TabletSY86e6f050-92c9-7b28-e053-2991aa0a97542
834102penicillin V potassium 500 MG Oral TabletPSN946783a7-500d-84d5-e053-2995a90a13f91
834102penicillin V potassium 500 MG Oral TabletSCD946783a7-500d-84d5-e053-2995a90a13f91
834102Penicillin V K+ 500 MG Oral TabletSY946783a7-500d-84d5-e053-2995a90a13f91
834102Penicillin V Pot 500 MG Oral TabletSY946783a7-500d-84d5-e053-2995a90a13f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-649-286191906492828 TABLET, FILM COATED in 1 BOTTLE (61919-649-28) 2019-04-190000-00-00NoNoCurrent
61919-649-306191906493030 TABLET, FILM COATED in 1 BOTTLE (61919-649-30) 2019-10-080000-00-00NoNoCurrent
61919-649-406191906494040 TABLET, FILM COATED in 1 BOTTLE (61919-649-40) 2019-04-190000-00-00NoNoCurrent