FDA.reportPublic FDA data

Application 060456

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN-VKPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 125MG BASE/5MLNoNo
002PENICILLIN-VKPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 250MG BASE/5MLNoYes

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
ndc (product): 68788-9853
ndc (product): 68788-9852
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.55a44735-6d6e-3012-e054-00144ff8d46c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456
ndc (product): 68071-1820
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
ndc (product): 0093-4125
ndc (product): 0093-4127
Penicillin V PotassiumPENICILLIN V POTASSIUMProficient Rx LP316aa904-09f1-4a8e-9adf-93cfc14f9a0a2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060456
application number: ANDA060456
ndc (product): 63187-533

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-4125Penicillin V PotassiumPenicillin V PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4125Penicillin V PotassiumPenicillin V PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4125Penicillin V PotassiumPenicillin V PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4127Penicillin V PotassiumPenicillin V PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4127Penicillin V PotassiumPenicillin V PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4127Penicillin V PotassiumPenicillin V PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-559Penicillin V PotassiumPenicillin V PotassiumRebel Distributors CorpANDACurrent
21695-772Penicillin V PotassiumPenicillin V PotassiumRebel Distributors CorpANDACurrent
50090-0408Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-0409Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
53002-2130Penicillin V PotassiumPenicillin V PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-2130Penicillin V PotassiumPenicillin V PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
63187-533Penicillin V PotassiumPenicillin V PotassiumProficient Rx LPANDACurrent
63187-533Penicillin V PotassiumPenicillin V PotassiumProficient Rx LPANDACurrent
68071-1778Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1806Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1820Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1820Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1820Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9852Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent
68788-9852Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent
68788-9852Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent
68788-9852Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent
68788-9853Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent
68788-9853Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent
68788-9853Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent
68788-9853Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, IncANDACurrent