Application 064071

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 250MG BASENoNo
002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 500MG BASENoYes

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
A064071-001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-30
A064071-002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-30

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORAL1995-11-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORAL1995-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB1995-11-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS1995-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB1995-11-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS1995-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB1995-11-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS1995-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB1995-11-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS1995-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB1995-11-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS1995-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064071-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB1995-11-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A064071-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS1995-11-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064071-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064071-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064071-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064071-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064071-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064071-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064071-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064071-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064071-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064071-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064071-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A064071-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064071-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064071-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A064071-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A064071-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064071-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A064071-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064071-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A064071-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064071-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A064071-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A064071-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A064071-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064071-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A064071-002AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12A064071-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A064071-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064071-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064071-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064071-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064071-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064071-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064071-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064071-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064071-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064071-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A064071-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064071-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A064071-002AB13bdfa0b2c4d7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.fba1ffe5-809a-495b-bf3e-f2099ac459f62026-07-28Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.8f9fa2c8-4d25-48a8-9257-43c33d08e83a2026-07-28Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.b5972712-f735-46ed-a94a-b84668bb6a822026-07-24Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMChartwell RX, LLCb0744674-ddf7-4022-be2f-2a22bef0d3792026-07-23Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMRedpharm Drug546c367a-c786-8326-e063-6294a90ae76c2026-07-14Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMProficient Rx LPb8f797fb-979c-4eab-a3a6-ad4edcb9ff072026-06-01Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.5f0759cc-c553-49b9-9049-80e7137589582026-04-09Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepack609c3e26-9220-4f3c-b393-a2b41b68de6c2026-03-12Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMQPharma Inc8c11af69-146f-47ed-b12a-7b201fec7e502025-12-04Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.ceddc406-4a17-471f-917e-63b4b03779ea2025-10-17Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.9bc7006d-a482-47c4-a138-5380ce9278122025-10-16Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.4ad879d4-eb32-49f0-af73-c47fc75819362025-10-15Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.450ad3aa-7c9e-497b-b00e-b1af0322f8d02025-10-15Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.0151c742-7525-4707-af03-bd48d50cd5862025-10-15Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.281f9c32-e28a-46ae-9e4e-c2143aaa6c6b2025-10-15Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.aa90bf0b-c08d-43e5-b247-1a5c5e3c94e42025-10-15Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.a251a769-280e-4024-ad7a-3177463258182025-10-09Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.73cd20d5-2521-4b93-a221-fa3fe490eba62025-10-08Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.dd8a48b2-9ff1-49de-a53e-db4964c2384c2025-10-02Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepackbdffe8fe-e6e0-4c08-894c-0653605ff4332025-09-26Warnings, Adverse reactionsName fallback
brand name: Penicillin V Potassium
generic name: PENICILLIN V POTASSIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1205Penicillin V PotasiumPenicillin V PotasiumSandoz IncANDACurrent
0781-1205Penicillin V PotasiumPenicillin V PotasiumSandoz IncANDACurrent
0781-1205Penicillin V PotasiumPenicillin V PotasiumSandoz IncANDACurrent
0781-1655Penicillin V PotasiumPenicillin V PotasiumSandoz IncANDACurrent
0781-1655Penicillin V PotasiumPenicillin V PotasiumSandoz IncANDACurrent
0781-1655Penicillin V PotasiumPenicillin V PotasiumSandoz IncANDACurrent
10544-975Penicillin V PotasiumPenicillin V PotasiumBlenheim Pharmacal, Inc.ANDACurrent
53217-290Penicillin V PotasiumPenicillin V PotasiumAidarex Pharmaceuticals LLCANDACurrent
55700-404Penicillin V PotasiumPenicillin V PotasiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
67296-0044Penicillin V PotasiumPenicillin V PotasiumRedPharm Drug, Inc.ANDACurrent
67296-0044Penicillin V PotasiumPenicillin V PotasiumRedPharm Drug, Inc.ANDACurrent
67296-0044Penicillin V PotasiumPenicillin V PotasiumRedPharm Drug, Inc.ANDACurrent
67296-1164Penicillin V PotasiumPenicillin V PotasiumRedPharm Drug, Inc.ANDACurrent
67296-1164Penicillin V PotasiumPenicillin V PotasiumRedPharm Drug, Inc.ANDACurrent
67296-1164Penicillin V PotasiumPenicillin V PotasiumRedPharm Drug, Inc.ANDACurrent
70518-2192Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2192Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2192Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2441Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2441Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2482Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2482Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2482Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent
70518-2529Penicillin V PotasiumPenicillin V PotasiumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18319SUPPL2014-02-06