FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
65862-176
11-digit product format
658620176
Labeler code
65862
Product ID
65862-176_7b3fb934-771d-4f76-9abe-8002861dd633
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
Rxcui834061, 834102

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-176-01Penicillin V Potassium100 in 1 BOTTLETABLET, FILM COATED10012
65862-176-05Penicillin V Potassium500 in 1 BOTTLETABLET, FILM COATED50012
65862-176-99Penicillin V Potassium1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-176-01EA - Each65862-1760ad9c2b3-bff4-447f-9059-e39e553969b812012-07-24
65862-176-05EA - Each65862-17673a0ae40-1bb8-4c13-953a-514c293019e812012-07-24
65862-176-99EA - Each65862-1765f2c37fb-f67d-49a8-87e5-0be075669f6f12012-07-24

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
PENICILLIN V POTASSIUMACTIVE INGREDIENT146T0TU1JBPENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
PENICILLIN VACTIVE MOIETYZ61I075U2WPENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
TALCINACTIVE INGREDIENT7SEV7J4R1UPENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-176PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 3 package rows20220221_cfc0df21-fb6f-447d-96f6-f851732f9e2f.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
834102penicillin V potassium 500 MG Oral TabletPSNaa90bf0b-c08d-43e5-b247-1a5c5e3c94e418
834102penicillin V potassium 500 MG Oral TabletSCDaa90bf0b-c08d-43e5-b247-1a5c5e3c94e418
834102Penicillin V K+ 500 MG Oral TabletSYaa90bf0b-c08d-43e5-b247-1a5c5e3c94e418
834102Penicillin V Pot 500 MG Oral TabletSYaa90bf0b-c08d-43e5-b247-1a5c5e3c94e418
834061penicillin V potassium 250 MG Oral TabletPSNcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834102penicillin V potassium 500 MG Oral TabletPSNcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834061penicillin V potassium 250 MG Oral TabletSCDcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834102penicillin V potassium 500 MG Oral TabletSCDcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834061Penicillin V K+ 250 MG Oral TabletSYcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834102Penicillin V K+ 500 MG Oral TabletSYcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834061Penicillin V Pot 250 MG Oral TabletSYcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834102Penicillin V Pot 500 MG Oral TabletSYcfc0df21-fb6f-447d-96f6-f851732f9e2f12
834102penicillin V potassium 500 MG Oral TabletPSN8c11af69-146f-47ed-b12a-7b201fec7e505
834102penicillin V potassium 500 MG Oral TabletPSN3eb1b1cc-edb5-6f0f-e054-00144ff88e885
834102penicillin V potassium 500 MG Oral TabletSCD8c11af69-146f-47ed-b12a-7b201fec7e505
834102penicillin V potassium 500 MG Oral TabletSCD3eb1b1cc-edb5-6f0f-e054-00144ff88e885
834102Penicillin V K+ 500 MG Oral TabletSY3eb1b1cc-edb5-6f0f-e054-00144ff88e885
834102Penicillin V K+ 500 MG Oral TabletSY8c11af69-146f-47ed-b12a-7b201fec7e505
834102Penicillin V Pot 500 MG Oral TabletSY8c11af69-146f-47ed-b12a-7b201fec7e505
834102Penicillin V Pot 500 MG Oral TabletSY3eb1b1cc-edb5-6f0f-e054-00144ff88e885
834102penicillin V potassium 500 MG Oral TabletPSN946dbeaa-17ec-4049-e053-2995a90a14624
834102penicillin V potassium 500 MG Oral TabletPSN4def54f4-087f-61d7-e054-00144ff8d46c4
834102penicillin V potassium 500 MG Oral TabletPSNc3efdc4b-bd91-485f-945f-f29f23aaa0064
834102penicillin V potassium 500 MG Oral TabletSCD946dbeaa-17ec-4049-e053-2995a90a14624
834102penicillin V potassium 500 MG Oral TabletSCD4def54f4-087f-61d7-e054-00144ff8d46c4
834102penicillin V potassium 500 MG Oral TabletSCDc3efdc4b-bd91-485f-945f-f29f23aaa0064
834102Penicillin V K+ 500 MG Oral TabletSY4def54f4-087f-61d7-e054-00144ff8d46c4
834102Penicillin V K+ 500 MG Oral TabletSYc3efdc4b-bd91-485f-945f-f29f23aaa0064
834102Penicillin V K+ 500 MG Oral TabletSY946dbeaa-17ec-4049-e053-2995a90a14624
834102Penicillin V Pot 500 MG Oral TabletSYc3efdc4b-bd91-485f-945f-f29f23aaa0064
834102Penicillin V Pot 500 MG Oral TabletSY4def54f4-087f-61d7-e054-00144ff8d46c4
834102Penicillin V Pot 500 MG Oral TabletSY946dbeaa-17ec-4049-e053-2995a90a14624
834102penicillin V potassium 500 MG Oral TabletPSN1c49ef5c-75bb-f9d4-e063-6394a90a951a3
834102penicillin V potassium 500 MG Oral TabletPSNe73087af-d485-42e2-8821-51d906e3eeaf3
834102penicillin V potassium 500 MG Oral TabletSCD1c49ef5c-75bb-f9d4-e063-6394a90a951a3
834102penicillin V potassium 500 MG Oral TabletSCDe73087af-d485-42e2-8821-51d906e3eeaf3
834102Penicillin V K+ 500 MG Oral TabletSYe73087af-d485-42e2-8821-51d906e3eeaf3
834102Penicillin V K+ 500 MG Oral TabletSY1c49ef5c-75bb-f9d4-e063-6394a90a951a3
834102Penicillin V Pot 500 MG Oral TabletSYe73087af-d485-42e2-8821-51d906e3eeaf3
834102Penicillin V Pot 500 MG Oral TabletSY1c49ef5c-75bb-f9d4-e063-6394a90a951a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-176-0165862017601100 TABLET, FILM COATED in 1 BOTTLE (65862-176-01) 2008-04-290000-00-00NoNoCurrent
65862-176-0565862017605500 TABLET, FILM COATED in 1 BOTTLE (65862-176-05) 2008-04-290000-00-00NoNoCurrent
65862-176-15658620176151500 TABLET, FILM COATED in 1 BAG (65862-176-15)29-APR-08Current
65862-176-99658620176991000 TABLET, FILM COATED in 1 BOTTLE (65862-176-99) 2008-04-290000-00-00NoNoCurrent