FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
43063-704
11-digit product format
430630704
Labeler code
43063
Product ID
43063-704_4147bed7-05e0-1bc4-e063-6294a90a04d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065435
Marketing category
ANDA
Marketing start
2008-04-29
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

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
43063-704-06Penicillin V Potassium6 in 1 BOTTLE, PLASTICTABLET, FILM COATED625
43063-704-20Penicillin V Potassium20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2025
43063-704-28Penicillin V Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2825
43063-704-40Penicillin V Potassium40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-704-06EA - Each43063-7045d3eb95d-1170-49a2-9ef1-7d51b574e0c812017-03-06
43063-704-20EA - Each43063-70477bce844-6e12-43c0-a8de-c63cbdc256ed12016-10-06
43063-704-28EA - Each43063-70486676696-c280-40b5-b435-fc2cca687dd812016-09-02
43063-704-40EA - Each43063-7047e7f414c-50ff-477f-8109-56737d51b88212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-704PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 4 package rows20241016_9bc7006d-a482-47c4-a138-5380ce927812.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSN9bc7006d-a482-47c4-a138-5380ce92781225
834061penicillin V potassium 250 MG Oral TabletSCD9bc7006d-a482-47c4-a138-5380ce92781225
834061Penicillin V K+ 250 MG Oral TabletSY9bc7006d-a482-47c4-a138-5380ce92781225
834061Penicillin V Pot 250 MG Oral TabletSY9bc7006d-a482-47c4-a138-5380ce92781225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-704-06430630704066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-06) 2016-11-020000-00-00NoNoCurrent
43063-704-204306307042020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-20) 2016-09-190000-00-00NoNoCurrent
43063-704-284306307042828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-28) 2016-08-220000-00-00NoNoCurrent
43063-704-404306307044040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-40) 2016-12-150000-00-00NoNoCurrent