FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
70518-2758
11-digit product format
705182758
Labeler code
70518
Product ID
70518-2758_5117d550-4260-bb0a-e063-6394a90a4b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065435
Marketing category
ANDA
Marketing start
2020-05-28
Substance
PENICILLIN V POTASSIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Penicillin V Potassium
Listing expiration
2027-12-31

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
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2758-0Penicillin V Potassium30 in 1 BLISTER PACKTABLET, FILM COATED3016
70518-2758-1Penicillin V Potassium28 in 1 BLISTER PACKTABLET, FILM COATED2816
70518-2758-2Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2016
70518-2758-3Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2016
70518-2758-4Penicillin V Potassium14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1416
70518-2758-5Penicillin V Potassium100 in 1 BOXTABLET, FILM COATED10016
70518-2758-6Penicillin V Potassium1 in 1 POUCHTABLET, FILM COATED116
70518-2758-7Penicillin V Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3016
70518-2758-8Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2816
70518-2758-9Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2816

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2758PENICILLIN V POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 10 package rows20250316_fba1ffe5-809a-495b-bf3e-f2099ac459f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSNfba1ffe5-809a-495b-bf3e-f2099ac459f616
834102penicillin V potassium 500 MG Oral TabletSCDfba1ffe5-809a-495b-bf3e-f2099ac459f616
834102Penicillin V K+ 500 MG Oral TabletSYfba1ffe5-809a-495b-bf3e-f2099ac459f616
834102Penicillin V Pot 500 MG Oral TabletSYfba1ffe5-809a-495b-bf3e-f2099ac459f616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2758-07051827580030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2758-0) 2020-05-280000-00-00NoNoCurrent
70518-2758-17051827580128 TABLET, FILM COATED in 1 BLISTER PACK (70518-2758-1) 2020-05-280000-00-00NoNoCurrent
70518-2758-27051827580220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2758-2) 2021-11-090000-00-00NoNoCurrent
70518-2758-37051827580320 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2758-3) 2022-04-080000-00-00NoNoCurrent
70518-2758-47051827580414 in 1 BOTTLE, PLASTICHistorical
70518-2758-570518275805100 in 1 BOXHistorical
70518-2758-6705182758061 in 1 POUCHHistorical
70518-2758-77051827580730 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2758-7) 2025-08-29NoNoHistorical
70518-2758-87051827580828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2758-8) 2025-11-24NoNoHistorical
70518-2758-97051827580928 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2758-9) 2026-05-05NoNoHistorical