Application 065435

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065435-001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29
A065435-002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065435-001AB
A065435-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2984e616aacf4f…
2026-09-14 22:38:342026-08A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-2974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065435-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065435-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065435-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065435-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065435-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065435-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065435-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065435-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065435-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065435-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065435-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065435-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065435-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065435-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065435-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065435-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065435-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065435-002AB174a2ff9319b5…

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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.861ccfaa-8b7a-0def-e053-2991aa0a1a392026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMRedpharm Drug58e6fd2f-e595-f788-e063-6394a90a0ea22026-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.fba1ffe5-809a-495b-bf3e-f2099ac459f62026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
ndc (product): 70518-2758
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.8f9fa2c8-4d25-48a8-9257-43c33d08e83a2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.b5972712-f735-46ed-a94a-b84668bb6a822026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
ndc (product): 70518-2808
Penicillin V PotassiumPENICILLIN V POTASSIUMRedpharm Drug546c367a-c786-8326-e063-6294a90ae76c2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMProficient Rx LPb8f797fb-979c-4eab-a3a6-ad4edcb9ff072026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMQPharma Inc8c11af69-146f-47ed-b12a-7b201fec7e502025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.9bc7006d-a482-47c4-a138-5380ce9278122025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.4ad879d4-eb32-49f0-af73-c47fc75819362025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.450ad3aa-7c9e-497b-b00e-b1af0322f8d02025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.0151c742-7525-4707-af03-bd48d50cd5862025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.281f9c32-e28a-46ae-9e4e-c2143aaa6c6b2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.aa90bf0b-c08d-43e5-b247-1a5c5e3c94e42025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.73cd20d5-2521-4b93-a221-fa3fe490eba62025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
ndc (product): 72789-146
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepackdde7b33e-84fc-41c9-97f8-10308841200d2025-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals, Inc.4af2a165-0b7d-2539-e054-00144ff8d46c2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.1c49ef5c-75bb-f9d4-e063-6394a90a951a2025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.946dbeaa-17ec-4049-e053-2995a90a14622025-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.fd784ff4-86ec-9ea4-e053-6394a90a89692025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 183 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1414Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-2758Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-2758Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-2758Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-2808Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-2877Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-2877Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-3052Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-3052Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70934-035Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc.ANDACurrent
70934-035Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. DBA Northwind Pharmaceuticals.ANDACurrent
70934-035Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. DBA Northwind Pharmaceuticals.ANDACurrent
70934-076Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. DBA NANDACurrent
70934-076Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-076Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-076Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-579Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-669Penicillin V PotassiumPenicillin V PotassiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
72789-146Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-146Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-146Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-146Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
82982-012Penicillin V PotassiumPenicillin V PotassiumPharmasource Meds LLCANDACurrent