FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
50090-0408
Requested package NDC
50090-0408-0
11-digit product format
500900408
Labeler code
50090
Product ID
50090-0408_fe3cd564-6937-45ff-9446-df613ff5f9c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA060456
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
PENICILLIN V POTASSIUM
Active strength
250 mg/5mL
Pharmacologic classes
Penicillins [CS],Penicillin-class Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-040850090-0408-0DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A060456-001PENICILLIN-VKPENICILLIN V POTASSIUMEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982
A060456-002PENICILLIN-VKPENICILLIN V POTASSIUMEQ 250MG BASE/5MLFOR SOLUTION / ORALRS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A060456-001PENICILLIN-VKEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A060456-002PENICILLIN-VKEQ 250MG BASE/5MLFOR SOLUTION / ORALRS, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMChartwell RX, LLCb0744674-ddf7-4022-be2f-2a22bef0d3792026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456
Penicillin V PotassiumPENICILLIN V POTASSIUMPreferred Pharmaceuticals, Inc8c342c78-47fb-4f6b-9451-68b1f752555c2025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.55a44735-6d6e-3012-e054-00144ff8d46c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutionsded0ee2e-56ae-41fe-949c-177614cd8e1f2023-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456
Penicillin V PotassiumPENICILLIN V POTASSIUMTeva Pharmaceuticals USA, Inc.3111ca84-6f8e-45ea-91a1-9cb99c63607e2023-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456
Penicillin V PotassiumPENICILLIN V POTASSIUMProficient Rx LP316aa904-09f1-4a8e-9adf-93cfc14f9a0a2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0408-02023-02-07C16284748780-1f386c649-afba-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
50090-0408-02023-01-30C16284748780-1f386c649-afba-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0408-0ML - Milliliter50090-04083bd99cbd-9ed8-4e66-a03a-cd43e49fc63012018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0408-050090040800100 mL in 1 BOTTLE (50090-0408-0) 100 ml2016-06-290000-00-00NoNoCurrent