Application 065271

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINCAPSULE;ORAL250MGNoNo
002AMOXICILLINAMOXICILLINCAPSULE;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A065271-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALAB2005-11-09
A065271-002AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALAB2005-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065271-001AB
A065271-002AB

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09c2088c7a36db…
2026-10-15 13:18:302026-09A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09c2088c7a36db…
2026-09-14 22:38:342026-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-094b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A065271-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A065271-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A065271-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065271-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065271-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065271-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065271-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065271-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065271-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065271-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065271-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065271-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065271-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065271-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065271-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065271-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065271-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065271-002AB14b0b4de00fa7…

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 2 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINQPharma Inc2772a745-1276-405b-b229-95edf5534b2a2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.071086f5-e4ed-b1d9-e063-6294a90ad3042025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINBryant Ranch Prepackbbaeb509-ad04-4668-a1db-4358038893f22025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.d0938df9-9065-47eb-9eae-0722ed1411a12025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.987786a1-d748-4b42-abb5-62a2f38ef1952025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINBryant Ranch Prepack1c755ad7-f0a8-4a63-a686-413bae57f8d02025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINBryant Ranch Prepack5d0132d0-1d5a-46d0-bc62-76d62a7bd19d2025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINBryant Ranch Prepackc0343d5e-96b2-46fa-bf54-e2ffa0c90b412025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINBryant Ranch Prepack95eaa9ac-c64a-4f1d-b5a3-66489d5b1edb2025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceutials,Inc.1f818d89-be59-b43d-e063-6394a90a12c32025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.d37f2e3c-01f0-4a81-a46f-1615b82e24992025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINA-S Medication Solutionse58a65d7-d813-446d-b70b-7465809a5d2c2025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINA-S Medication Solutions641ec2a8-368a-4c5c-8c11-37366a06ce932025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINA-S Medication Solutions9d56f34f-c025-4e97-8f5e-4d93f1ab00552025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINA-S Medication Solutions4b15c5b4-460c-449f-9e48-99870b3828262025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINAmerican Health Packagingecb439f7-434a-4e4c-b899-943d83346f092025-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4f1c940c-9f17-4289-e054-00144ff88e882025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINRedpharm Drugfc61c9f5-b0f8-3ff8-e053-6394a90adeb72025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.6d7143e3-6a82-3613-e053-2a91aa0a8f652025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNorthwind Pharmaceuticals, LLC26114563-c719-46da-b976-3e4271533f282025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271

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 · 203 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-4953AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4953AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5019AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5019AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6369AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6369AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6369AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6369AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6369AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7141AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7141AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7141AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7141AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7141AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8209AmoxicillinAmoxicillinPreferred Phamraceuticals Inc.ANDACurrent
68788-8240AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-8972AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-9710AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9786AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0748AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-0748AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-0895AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-0895AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-0895AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-0929AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-0929AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-3294AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70518-3294AmoxicillinAmoxicillinREMEDYREPACK INC.ANDACurrent
70934-033AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-033AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-033AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-154AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-154AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-154AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-407AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-407AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-407AmoxicillinAmoxicillinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-507AmoxicillinAmoxicillinProficient Rx LPANDACurrent
71205-507AmoxicillinAmoxicillinProficient Rx LPANDACurrent
76413-143AmoxicillinAmoxicillinCentral Texas Community Health CentersANDACurrent
76420-112AmoxicillinAmoxicillinAsclemed USA, Inc.ANDACurrent
76420-508AmoxicillinAmoxicillinAsclemed USA, Inc.ANDACurrent
83112-031Amoxicillin 500 mgAmoxicillinHealth Department, Oklahoma StateANDACurrent