FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
43063-780
11-digit product format
430630780
Labeler code
43063
Product ID
43063-780_2c25446b-961e-ee26-e063-6394a90a7385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
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
43063-780-06Penicillin V Potassium6 in 1 BOTTLE, PLASTICTABLET, FILM COATED623
43063-780-15Penicillin V Potassium15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1523
43063-780-20Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2023
43063-780-28Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2823
43063-780-30Penicillin V Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
43063-780-40Penicillin V Potassium40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-780-06EA - Each43063-7801f85612e-3e60-47a5-bab1-bcd2f47342b012020-09-14
43063-780-15EA - Each43063-7805281fa55-9ded-4706-9086-96d8d3970b3212017-10-13
43063-780-20EA - Each43063-7808f73e1dc-03f2-4436-b71f-f2124319304a12017-11-06
43063-780-28EA - Each43063-780d46eb488-058d-4258-9f4e-621947e8832c12018-04-19
43063-780-30EA - Each43063-780f7f6506f-67c8-4885-8387-5a2e5292a51912017-09-11
43063-780-40EA - Each43063-780a3c53b31-581d-4299-b1b2-b660f602c44c12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-780PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 6 package rows20250121_f3f5947d-0dd3-4b50-93a2-bc8325180978.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSNf3f5947d-0dd3-4b50-93a2-bc832518097823
834102penicillin V potassium 500 MG Oral TabletSCDf3f5947d-0dd3-4b50-93a2-bc832518097823
834102Penicillin V K+ 500 MG Oral TabletSYf3f5947d-0dd3-4b50-93a2-bc832518097823
834102Penicillin V Pot 500 MG Oral TabletSYf3f5947d-0dd3-4b50-93a2-bc832518097823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-780-06430630780066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-06) 2020-08-040000-00-00NoNoCurrent
43063-780-154306307801515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-15) 2017-09-010000-00-00NoNoCurrent
43063-780-204306307802020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-20) 2017-09-270000-00-00NoNoCurrent
43063-780-284306307802828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-28) 2018-03-050000-00-00NoNoCurrent
43063-780-304306307803030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-30) 2018-08-070000-00-00NoNoCurrent
43063-780-404306307804040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-780-40) 2018-08-070000-00-00NoNoCurrent