FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
0143-9836
11-digit product format
001439836
Labeler code
0143
Product ID
0143-9836_dd8905b6-bf91-4624-bad7-ad27b01f8113
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090549
Marketing category
ANDA
Marketing start
2013-10-11
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
Rxcui834061, 834102

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
0143-9836-01Penicillin V Potassium100 in 1 BOTTLETABLET, FILM COATED10017
0143-9836-10Penicillin V Potassium1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9836-01EA - Each0143-98367bea914b-66b4-4fb6-81a9-28dbe60821ce12017-05-03
0143-9836-10EA - Each0143-983603345580-ec77-4d46-a2e6-040c72d3fdff12017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN V POTASSIUMACTIVE INGREDIENT146T0TU1JBPENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
PENICILLIN VACTIVE MOIETYZ61I075U2WPENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENICILLIN V POTASSIUM TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9836PENICILLIN V POTASSIUM TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.]17Current NDC, Legacy NDC, 2 package rows20240627_dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSNe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834102penicillin V potassium 500 MG Oral TabletPSNe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834102penicillin V potassium 500 MG Oral TabletPSNf3f5947d-0dd3-4b50-93a2-bc832518097823
834061penicillin V potassium 250 MG Oral TabletSCDe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834102penicillin V potassium 500 MG Oral TabletSCDe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834102penicillin V potassium 500 MG Oral TabletSCDf3f5947d-0dd3-4b50-93a2-bc832518097823
834061Penicillin V K+ 250 MG Oral TabletSYe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834102Penicillin V K+ 500 MG Oral TabletSYf3f5947d-0dd3-4b50-93a2-bc832518097823
834102Penicillin V K+ 500 MG Oral TabletSYe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834061Penicillin V Pot 250 MG Oral TabletSYe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834102Penicillin V Pot 500 MG Oral TabletSYf3f5947d-0dd3-4b50-93a2-bc832518097823
834102Penicillin V Pot 500 MG Oral TabletSYe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834061penicillin V potassium 250 MG Oral TabletPSN7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834102penicillin V potassium 500 MG Oral TabletPSN7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834061penicillin V potassium 250 MG Oral TabletSCD7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834102penicillin V potassium 500 MG Oral TabletSCD7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834061Penicillin V K+ 250 MG Oral TabletSY7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834102Penicillin V K+ 500 MG Oral TabletSY7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834061Penicillin V Pot 250 MG Oral TabletSY7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834102Penicillin V Pot 500 MG Oral TabletSY7aef4c8b-aee7-453d-bb6f-fce8e4588e3b21
834102penicillin V potassium 500 MG Oral TabletPSNceddc406-4a17-471f-917e-63b4b03779ea18
834102penicillin V potassium 500 MG Oral TabletSCDceddc406-4a17-471f-917e-63b4b03779ea18
834102Penicillin V K+ 500 MG Oral TabletSYceddc406-4a17-471f-917e-63b4b03779ea18
834102Penicillin V Pot 500 MG Oral TabletSYceddc406-4a17-471f-917e-63b4b03779ea18
834061penicillin V potassium 250 MG Oral TabletPSNdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834102penicillin V potassium 500 MG Oral TabletPSNdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834061penicillin V potassium 250 MG Oral TabletSCDdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834102penicillin V potassium 500 MG Oral TabletSCDdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834061Penicillin V K+ 250 MG Oral TabletSYdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834102Penicillin V K+ 500 MG Oral TabletSYdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834061Penicillin V Pot 250 MG Oral TabletSYdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834102Penicillin V Pot 500 MG Oral TabletSYdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
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
834102penicillin V potassium 500 MG Oral TabletPSNf423d112-5706-cdf7-e053-2a95a90a1bbb4
834102penicillin V potassium 500 MG Oral TabletPSN56192625-0564-4131-94b2-8b9c6a0b53b04
834102penicillin V potassium 500 MG Oral TabletSCD56192625-0564-4131-94b2-8b9c6a0b53b04
834102penicillin V potassium 500 MG Oral TabletSCDf423d112-5706-cdf7-e053-2a95a90a1bbb4
834102Penicillin V K+ 500 MG Oral TabletSYf423d112-5706-cdf7-e053-2a95a90a1bbb4
834102Penicillin V K+ 500 MG Oral TabletSY56192625-0564-4131-94b2-8b9c6a0b53b04
834102Penicillin V Pot 500 MG Oral TabletSY56192625-0564-4131-94b2-8b9c6a0b53b04
834102Penicillin V Pot 500 MG Oral TabletSYf423d112-5706-cdf7-e053-2a95a90a1bbb4
834102penicillin V potassium 500 MG Oral TabletPSNe2adf44c-5e0d-e974-e053-2995a90a3d161
834102penicillin V potassium 500 MG Oral TabletPSN59ff8dd6-534c-4e7a-9d8b-380c23a9c2e51
834102penicillin V potassium 500 MG Oral TabletSCDe2adf44c-5e0d-e974-e053-2995a90a3d161
834102penicillin V potassium 500 MG Oral TabletSCD59ff8dd6-534c-4e7a-9d8b-380c23a9c2e51
834102Penicillin V K+ 500 MG Oral TabletSYe2adf44c-5e0d-e974-e053-2995a90a3d161
834102Penicillin V K+ 500 MG Oral TabletSY59ff8dd6-534c-4e7a-9d8b-380c23a9c2e51
834102Penicillin V Pot 500 MG Oral TabletSYe2adf44c-5e0d-e974-e053-2995a90a3d161
834102Penicillin V Pot 500 MG Oral TabletSY59ff8dd6-534c-4e7a-9d8b-380c23a9c2e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9836-0100143983601100 TABLET, FILM COATED in 1 BOTTLE (0143-9836-01) 2013-10-110000-00-00NoNoCurrent
0143-9836-10001439836101000 TABLET, FILM COATED in 1 BOTTLE (0143-9836-10) 2013-10-110000-00-00NoNoCurrent