FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
68071-3640
11-digit product format
680713640
Labeler code
68071
Product ID
68071-3640_337a4a2b-491a-2698-e063-6294a90aab3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065435
Marketing category
ANDA
Marketing start
2008-04-29
Substance
PENICILLIN V POTASSIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Penicillin V Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN V POTASSIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii146T0TU1JB
Rxcui834102

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3640-3Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED303
68071-3640-4Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED403
68071-3640-8Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3640PENICILLIN V POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 3 package rows20250425_1c49ef5c-75bb-f9d4-e063-6394a90a951a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN1c49ef5c-75bb-f9d4-e063-6394a90a951a3
834102penicillin V potassium 500 MG Oral TabletSCD1c49ef5c-75bb-f9d4-e063-6394a90a951a3
834102Penicillin V K+ 500 MG Oral TabletSY1c49ef5c-75bb-f9d4-e063-6394a90a951a3
834102Penicillin V Pot 500 MG Oral TabletSY1c49ef5c-75bb-f9d4-e063-6394a90a951a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3640-36807136400330 TABLET, FILM COATED in 1 BOTTLE (68071-3640-3) 2024-07-02NoNoCurrent
68071-3640-46807136400440 TABLET, FILM COATED in 1 BOTTLE (68071-3640-4) 2025-02-28NoNoCurrent
68071-3640-86807136400828 TABLET, FILM COATED in 1 BOTTLE (68071-3640-8) 2025-04-23NoNoCurrent