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 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
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 · 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 UTC2026-02A065271-001AMOXICILLIN250MGCAPSULE / 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…
2019-12-13 00:20 UTC2019-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2019-12-13 00:20 UTC2019-12A065271-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065271-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065271-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065271-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065271-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065271-002AB1782e0a99824c…

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 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4a402dba-c255-5db8-e054-00144ff8d46c2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8cb987bf-d45a-c15a-e053-2995a90aad462026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
ndc (product): 68071-4953
AmoxicillinAMOXICILLINHAWAII REPACK, INC.bf130964-8386-4ab7-8d3b-fb0174670afc2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNorthwind Health Company, LLC1d0d8bc4-137e-ef10-e063-6294a90acf622026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.53548597-347b-42a9-916c-e88cd27b8dcd2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
ndc (product): 70518-0895
AmoxicillinAMOXICILLINREMEDYREPACK INC.3a4afd36-dffa-44a1-9d09-e93cf66053bf2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINProficient Rx LPef03286b-4ba7-4952-9ab1-90cacf3005042026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5155ca5d-fe58-42b4-e063-6394a90ab1352026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINCoupler LLC5020950a-b248-a463-e063-6294a90ae57f2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.afb4149a-0714-4a85-b9e8-2379a8e6a3022026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
ndc (product): 70518-3294
AmoxicillinAMOXICILLINSportpharm LLC9bb2856b-feef-4063-befc-2dd9175028982026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPreferred Phamraceuticals Inc.47424822-14a1-48e0-a62d-df34fe6857262026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
ndc (product): 68788-8209
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.d6a33b28-f520-4a4c-b553-0ebd005583452026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
ndc (product): 68788-8240
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.800f5fac-f2af-358f-e053-2a91aa0ad6a62026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINSportpharm LLCd55dd9d9-e901-47b6-b496-5f2749726a2e2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
Amoxicillin 500 mgAMOXICILLINHealth Department, Oklahoma Statef049551b-4708-eb13-e053-2a95a90afd1f2025-12-13Exact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINAsclemed USA, Inc.32b224c2-1354-4b58-b082-b93330e6962b2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
ndc (product): 76420-112
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

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