FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
43063-622
11-digit product format
430630622
Labeler code
43063
Product ID
43063-622_4139b076-f92d-057b-e063-6294a90a383d
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
43063-622-40Penicillin V Potassium40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN V POTASSIUMACTIVE INGREDIENT146T0TU1JBPENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
PENICILLIN VACTIVE MOIETYZ61I075U2WPENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UPENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-622PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 1 package rows20241013_281f9c32-e28a-46ae-9e4e-c2143aaa6c6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN281f9c32-e28a-46ae-9e4e-c2143aaa6c6b15
834061penicillin V potassium 250 MG Oral TabletSCD281f9c32-e28a-46ae-9e4e-c2143aaa6c6b15
834061Penicillin V K+ 250 MG Oral TabletSY281f9c32-e28a-46ae-9e4e-c2143aaa6c6b15
834061Penicillin V Pot 250 MG Oral TabletSY281f9c32-e28a-46ae-9e4e-c2143aaa6c6b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-622-404306306224040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-622-40) 2015-10-260000-00-00NoNoCurrent