FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
43063-557
11-digit product format
430630557
Labeler code
43063
Product ID
43063-557_4139485a-ad19-e45d-e063-6394a90a60f9
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
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
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-557-04Penicillin V Potassium4 in 1 BOTTLE, PLASTICTABLET, FILM COATED426
43063-557-06Penicillin V Potassium6 in 1 BOTTLE, PLASTICTABLET, FILM COATED626
43063-557-15Penicillin V Potassium15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1526
43063-557-20Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2026
43063-557-28Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2826
43063-557-30Penicillin V Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3026
43063-557-40Penicillin V Potassium40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-557-04EA - Each43063-55756b4a5c8-e6da-49f0-9ca4-bd03ea2313df12017-03-06
43063-557-06EA - Each43063-557da5be44f-f587-4539-81de-ae66f8e30eb612017-03-06
43063-557-15EA - Each43063-557d144b673-a3ca-471e-8ce5-f7634ab7707212016-12-07
43063-557-20EA - Each43063-557b3f1f78d-5551-40f3-864b-8db57d20557712016-10-06
43063-557-28EA - Each43063-557ecfdb6e5-6de5-439c-80fc-9fc0eee776e312015-02-02
43063-557-30EA - Each43063-557b0c5572b-3498-454a-a425-8803d28bb2d512016-09-02
43063-557-40EA - Each43063-557e3f8a50c-0337-4c34-a289-948ec41c9c8812015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN V POTASSIUMACTIVE INGREDIENT146T0TU1JBPENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
PENICILLIN VACTIVE MOIETYZ61I075U2WPENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UPENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-557PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 7 package rows20241019_4ad879d4-eb32-49f0-af73-c47fc7581936.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN4ad879d4-eb32-49f0-af73-c47fc758193626
834102penicillin V potassium 500 MG Oral TabletSCD4ad879d4-eb32-49f0-af73-c47fc758193626
834102Penicillin V K+ 500 MG Oral TabletSY4ad879d4-eb32-49f0-af73-c47fc758193626
834102Penicillin V Pot 500 MG Oral TabletSY4ad879d4-eb32-49f0-af73-c47fc758193626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-557-04430630557044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-04) 2016-12-130000-00-00NoNoCurrent
43063-557-06430630557066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-06) 2016-12-130000-00-00NoNoCurrent
43063-557-154306305571515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-15) 2016-10-240000-00-00NoNoCurrent
43063-557-204306305572020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-20) 2016-09-130000-00-00NoNoCurrent
43063-557-284306305572828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-28) 2015-01-230000-00-00NoNoCurrent
43063-557-304306305573030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-30) 2016-08-240000-00-00NoNoCurrent
43063-557-404306305574040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-40) 2015-03-180000-00-00NoNoCurrent