FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
70518-3441
11-digit product format
705183441
Labeler code
70518
Product ID
70518-3441_4f08f45c-64a5-c32b-e063-6294a90a2e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090549
Marketing category
ANDA
Marketing start
2022-06-22
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
70518-3441-0Penicillin V Potassium100 in 1 BOXTABLET, FILM COATED1009
70518-3441-1Penicillin V Potassium1 in 1 POUCHTABLET, FILM COATED19
70518-3441-2Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED209
70518-3441-3Penicillin V Potassium40 in 1 BOTTLE, PLASTICTABLET, FILM COATED409
70518-3441-4Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED289
70518-3441-5Penicillin V Potassium14 in 1 BOTTLE, PLASTICTABLET, FILM COATED149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3441PENICILLIN V POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 6 package rows20241023_5f0759cc-c553-49b9-9049-80e713758958.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN5f0759cc-c553-49b9-9049-80e7137589589
834102penicillin V potassium 500 MG Oral TabletSCD5f0759cc-c553-49b9-9049-80e7137589589
834102Penicillin V K+ 500 MG Oral TabletSY5f0759cc-c553-49b9-9049-80e7137589589
834102Penicillin V Pot 500 MG Oral TabletSY5f0759cc-c553-49b9-9049-80e7137589589

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3441-070518344100100 POUCH in 1 BOX (70518-3441-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3441-1) 100 pouch2022-06-220000-00-00NoNoCurrent
70518-3441-1705183441011 in 1 POUCHHistorical
70518-3441-27051834410220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3441-2) 2023-08-21NoNoCurrent
70518-3441-37051834410340 in 1 BOTTLE, PLASTICHistorical
70518-3441-47051834410428 in 1 BOTTLE, PLASTICHistorical
70518-3441-57051834410514 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3441-5) 2025-06-20NoNoCurrent