FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
72789-146
11-digit product format
727890146
Labeler code
72789
Product ID
72789-146_40a6a8aa-9b9e-8638-e063-6294a90af659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065435
Marketing category
ANDA
Marketing start
2008-04-29
Substance
PENICILLIN V POTASSIUM
Active strength
250 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 POTASSIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii146T0TU1JB
Rxcui834061

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
72789-146-06Penicillin V Potassium6 in 1 BOTTLE, PLASTICTABLET, FILM COATED614
72789-146-20Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2014
72789-146-28Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-146-06EA - Each72789-146f373859e-6df1-4019-9cdd-0b8a2cccfe8812021-02-05
72789-146-20EA - Each72789-14673ab8fdb-0de7-49bc-8be5-90aca494d8af12021-01-08
72789-146-28EA - Each72789-146f51e468c-8451-436b-bf24-33679b06504d12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-146PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20240713_73cd20d5-2521-4b93-a221-fa3fe490eba6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN73cd20d5-2521-4b93-a221-fa3fe490eba614
834061penicillin V potassium 250 MG Oral TabletSCD73cd20d5-2521-4b93-a221-fa3fe490eba614
834061Penicillin V K+ 250 MG Oral TabletSY73cd20d5-2521-4b93-a221-fa3fe490eba614
834061Penicillin V Pot 250 MG Oral TabletSY73cd20d5-2521-4b93-a221-fa3fe490eba614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-146-06727890146066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-146-06) 2020-12-300000-00-00NoNoCurrent
72789-146-207278901462020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-146-20) 2020-12-300000-00-00NoNoCurrent
72789-146-287278901462828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-146-28) 2021-03-150000-00-00NoNoCurrent