FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
0143-9837
11-digit product format
001439837
Labeler code
0143
Product ID
0143-9837_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
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, 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
0143-9837-01Penicillin V Potassium100 in 1 BOTTLETABLET, FILM COATED10017
0143-9837-10Penicillin V Potassium1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9837-01EA - Each0143-983738ffbb2a-9abe-494e-b49e-5fb17f92433d12017-05-03
0143-9837-10EA - Each0143-9837d92fd63d-b666-4553-b039-c9b8c7c2973112017-05-03

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
0143-9837PENICILLIN 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
834061penicillin V potassium 250 MG Oral TabletSCDe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834102penicillin V potassium 500 MG Oral TabletSCDe4642fb3-2db9-49d3-8fd4-ceb750f7043723
834061Penicillin V K+ 250 MG Oral TabletSYe4642fb3-2db9-49d3-8fd4-ceb750f7043723
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 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
834061penicillin V potassium 250 MG Oral TabletPSN8d98ea77-f237-4b93-87fa-41f556436ab518
834061penicillin V potassium 250 MG Oral TabletSCD8d98ea77-f237-4b93-87fa-41f556436ab518
834061Penicillin V K+ 250 MG Oral TabletSY8d98ea77-f237-4b93-87fa-41f556436ab518
834061Penicillin V Pot 250 MG Oral TabletSY8d98ea77-f237-4b93-87fa-41f556436ab518
834061penicillin V potassium 250 MG Oral TabletPSNdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834061penicillin V potassium 250 MG Oral TabletPSNa251a769-280e-4024-ad7a-31774632581817
834102penicillin V potassium 500 MG Oral TabletPSNdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834061penicillin V potassium 250 MG Oral TabletSCDa251a769-280e-4024-ad7a-31774632581817
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
834061Penicillin V K+ 250 MG Oral TabletSYa251a769-280e-4024-ad7a-31774632581817
834102Penicillin V K+ 500 MG Oral TabletSYdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834061Penicillin V Pot 250 MG Oral TabletSYa251a769-280e-4024-ad7a-31774632581817
834061Penicillin V Pot 250 MG Oral TabletSYdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834102Penicillin V Pot 500 MG Oral TabletSYdc33f7a4-348b-4b4c-a5f2-c4f908fda4aa17
834061penicillin V potassium 250 MG Oral TabletPSN93c1177c-35da-464b-be90-bb18fe9bd27d9
834061penicillin V potassium 250 MG Oral TabletSCD93c1177c-35da-464b-be90-bb18fe9bd27d9
834061Penicillin V K+ 250 MG Oral TabletSY93c1177c-35da-464b-be90-bb18fe9bd27d9
834061Penicillin V Pot 250 MG Oral TabletSY93c1177c-35da-464b-be90-bb18fe9bd27d9
834061penicillin V potassium 250 MG Oral TabletPSNfbd3f219-d052-fd00-e053-6294a90a66ac2
834061penicillin V potassium 250 MG Oral TabletPSNf423ca90-90b9-c716-e053-2a95a90a859d2
834061penicillin V potassium 250 MG Oral TabletSCDfbd3f219-d052-fd00-e053-6294a90a66ac2
834061penicillin V potassium 250 MG Oral TabletSCDf423ca90-90b9-c716-e053-2a95a90a859d2
834061Penicillin V K+ 250 MG Oral TabletSYfbd3f219-d052-fd00-e053-6294a90a66ac2
834061Penicillin V K+ 250 MG Oral TabletSYf423ca90-90b9-c716-e053-2a95a90a859d2
834061Penicillin V Pot 250 MG Oral TabletSYf423ca90-90b9-c716-e053-2a95a90a859d2
834061Penicillin V Pot 250 MG Oral TabletSYfbd3f219-d052-fd00-e053-6294a90a66ac2
834061penicillin V potassium 250 MG Oral TabletPSNbdffe8fe-e6e0-4c08-894c-0653605ff4331
834061penicillin V potassium 250 MG Oral TabletPSN609c3e26-9220-4f3c-b393-a2b41b68de6c1
834061penicillin V potassium 250 MG Oral TabletSCD609c3e26-9220-4f3c-b393-a2b41b68de6c1
834061penicillin V potassium 250 MG Oral TabletSCDbdffe8fe-e6e0-4c08-894c-0653605ff4331
834061Penicillin V K+ 250 MG Oral TabletSYbdffe8fe-e6e0-4c08-894c-0653605ff4331
834061Penicillin V K+ 250 MG Oral TabletSY609c3e26-9220-4f3c-b393-a2b41b68de6c1
834061Penicillin V Pot 250 MG Oral TabletSYbdffe8fe-e6e0-4c08-894c-0653605ff4331
834061Penicillin V Pot 250 MG Oral TabletSY609c3e26-9220-4f3c-b393-a2b41b68de6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9837-0100143983701100 TABLET, FILM COATED in 1 BOTTLE (0143-9837-01) 2013-10-110000-00-00NoNoCurrent
0143-9837-10001439837101000 TABLET, FILM COATED in 1 BOTTLE (0143-9837-10) 2013-10-110000-00-00NoNoCurrent