FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
63187-756
11-digit product format
631870756
Labeler code
63187
Product ID
63187-756_f537d5d2-a239-49e0-9811-3b5e6526f728
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
63187-756-20Penicillin V Potassium20 in 1 BOTTLETABLET, FILM COATED203
63187-756-30Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED303
63187-756-40Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-756-20EA - Each63187-756654e427c-7934-4ffa-bdff-b3ccc980435112025-08-11
63187-756-30EA - Each63187-756fb0e10f9-d9bf-43b6-baaa-66ce8986de6912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-756PENICILLIN V POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191121_e73087af-d485-42e2-8821-51d906e3eeaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSNe73087af-d485-42e2-8821-51d906e3eeaf3
834102penicillin V potassium 500 MG Oral TabletSCDe73087af-d485-42e2-8821-51d906e3eeaf3
834102Penicillin V K+ 500 MG Oral TabletSYe73087af-d485-42e2-8821-51d906e3eeaf3
834102Penicillin V Pot 500 MG Oral TabletSYe73087af-d485-42e2-8821-51d906e3eeaf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-756-206318707562020 TABLET, FILM COATED in 1 BOTTLE (63187-756-20) 2016-11-010000-00-00NoNoCurrent
63187-756-306318707563030 TABLET, FILM COATED in 1 BOTTLE (63187-756-30) 2016-11-010000-00-00NoNoCurrent
63187-756-406318707564040 TABLET, FILM COATED in 1 BOTTLE (63187-756-40) 2016-11-010000-00-00NoNoCurrent