FDA.reportPublic FDA data

Penicillin V Potassium

Product NDC
50090-0409
11-digit product format
500900409
Labeler code
50090
Product ID
50090-0409_acce0bbf-684d-4c34-9d79-ce1514bfd2ab
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
Substance
PENICILLIN V POTASSIUM
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
ndc (product): 50090-0409
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

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/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
146T0TU1JBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834040Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ded0ee2e-56ae-41fe-949c-177614cd8e1fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0409-02023-02-07C16284748780-1f386c649-ca08-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
50090-0409-02023-01-30C16284748780-1f386c649-ca08-0266-e053-dadaa90a7c1aPenicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0409-0Penicillin V Potassium200 mL in 1 BOTTLEPOWDER, FOR SOLUTION20010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0409-0ML - Milliliter50090-04097a7c866e-2db5-42af-ac68-79b7786a066e12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0409PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 1 package rows20230926_ded0ee2e-56ae-41fe-949c-177614cd8e1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834040penicillin V potassium 250 MG in 5 mL Oral SolutionPSNded0ee2e-56ae-41fe-949c-177614cd8e1f10
834040penicillin V potassium 50 MG/ML Oral SolutionSCDded0ee2e-56ae-41fe-949c-177614cd8e1f10
834040Penicillin V K+ 50 MG/ML Oral SolutionSYded0ee2e-56ae-41fe-949c-177614cd8e1f10
834040Penicillin V Pot 50 MG/ML Oral SolutionSYded0ee2e-56ae-41fe-949c-177614cd8e1f10
834040penicillin V potassium 250 MG per 5 ML Oral SolutionSYded0ee2e-56ae-41fe-949c-177614cd8e1f10
834040phenoxymethylpenicillin potassium 50 MG/ML Oral SolutionSYded0ee2e-56ae-41fe-949c-177614cd8e1f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0409-050090040900200 mL in 1 BOTTLE (50090-0409-0) 200 ml2016-06-290000-00-00NoNoCurrent