FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
68788-8242
11-digit product format
687888242
Labeler code
68788
Product ID
68788-8242_f750aa5e-5596-4c7f-956c-2eeb130c1ed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090549
Marketing category
ANDA
Marketing start
2022-08-09
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
68788-8242-2Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED284
68788-8242-4Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8242-2EA - Each68788-8242b20d4d3f-b190-4965-b310-344cd5445af112022-09-12
68788-8242-4EA - Each68788-82426bbb1e62-4af7-48a8-b6dc-65951e04b74a12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8242PENICILLIN V POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240730_56192625-0564-4131-94b2-8b9c6a0b53b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN56192625-0564-4131-94b2-8b9c6a0b53b04
834102penicillin V potassium 500 MG Oral TabletSCD56192625-0564-4131-94b2-8b9c6a0b53b04
834102Penicillin V K+ 500 MG Oral TabletSY56192625-0564-4131-94b2-8b9c6a0b53b04
834102Penicillin V Pot 500 MG Oral TabletSY56192625-0564-4131-94b2-8b9c6a0b53b04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8242-26878882420228 TABLET, FILM COATED in 1 BOTTLE (68788-8242-2) 2022-08-090000-00-00NoNoCurrent
68788-8242-46878882420440 TABLET, FILM COATED in 1 BOTTLE (68788-8242-4) 2022-08-090000-00-00NoNoCurrent