Application 065253

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 250MG BASENoNo
002CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 500MG BASENoNo
003CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 750MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065253-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16
A065253-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16
A065253-003CEPHALEXINCEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065253-001AB
A065253-002AB
A065253-003AB

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 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001AB18072bd15b7f6…

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 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.2506895d-f3e0-4be9-95cb-7a6fd44de46d2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
ndc (product): 70518-3066
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.88426cb3-1c0c-439b-9f1a-aa169040c29f2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNorthwind Health Company, LLC1d0d50ba-8c2c-855c-e063-6394a90a5c7d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack47b6bc70-e8cc-4837-a39a-6998ee4e37dc2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack8a938dd0-fca6-4f22-9fb0-6325966030012026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.52d8a080-eafc-46fe-82d9-6b69c6a3a38a2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINChartwell RX, LLCd315cce8-9784-419e-818b-16d68d1dbd6e2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0b3da88f-f513-cdf0-e063-6394a90a72052025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack2070b988-f7fb-4e35-91e3-1b7df5e5326c2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINAMELLA PHARMA, LLC602fae70-3b8a-4f09-8db1-41fef4a2ecd72025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
ndc (product): 72287-310
CephalexinCEPHALEXINREMEDYREPACK INC.c0ca008e-0e28-412e-a58f-70f63817713b2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf3b46058-3e53-413b-b9c9-7d49e50f861e2025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack88a744d8-a95e-4c63-8b25-52f5039b6ba12025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0aad51b4-86d5-e312-e063-6394a90a250d2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack50f0187b-09e7-4c11-970f-91cd1877fde12025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack905b3270-abbd-4d5c-b313-3d20eb4b4c572025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf2e73727-2ab6-4418-9677-19ea1d140bbd2025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINCoupler, LLC30b7071e-cef1-bd41-e063-6394a90ad48e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals, Inc.28da5822-fb0b-1306-e063-6394a90a6e4c2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINA-S Medication Solutions02b5cd6f-3df8-43c1-879d-217fcf55231a2025-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
ndc (product): 50090-0081

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7244CephalexinCephalexinLiberty Pharmaceuticals, Inc.ANDACurrent
10544-004CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
10544-142CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
21695-316CephalexinCephalexinRebel Distributors Corp.ANDACurrent
21695-317CephalexinCephalexinRebel Distributors Corp.ANDACurrent
45865-428CephalexinCephalexinMedsource PharmaceuticalsANDACurrent
45865-428CephalexinCephalexinMedsource PharmaceuticalsANDACurrent
50090-0070CephalexinCephalexinA-S Medication SolutionsANDACurrent
50090-0070CephalexinCephalexinA-S Medication SolutionsANDACurrent
50090-0079CephalexinCephalexinA-S Medication SolutionsANDACurrent
50090-0081CephalexinCephalexinA-S Medication SolutionsANDACurrent
51655-026CephalexinCephalexinNorthwind Pharmaceuticals, LLCANDACurrent
52343-001CephalexinCephalexinGen-Source RxANDACurrent
52343-002CephalexinCephalexinGen-Source RxANDACurrent
55700-043CephalexinCephalexinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-145CephalexinCephalexinQuality Care Products, LLCANDACurrent
65862-018CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
65862-018CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
65862-018CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
65862-018CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
65862-019CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
65862-019CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
65862-019CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
65862-019CephalexinCephalexinAurobindo Pharma LimitedANDACurrent
66116-400CephalexinCephalexinMedVantx, Inc.ANDACurrent
66336-055CephalexinCephalexinDispensing Solutions, Inc.ANDACurrent
68788-9404CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9404CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9404CephalexinCephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
69043-008CephalexinCephalexinCronus Pharma LLCANDACurrent
69043-008CephalexinCephalexinCronus Pharma LLCANDACurrent
69043-009CephalexinCephalexinCronus Pharma LLCANDACurrent
69043-009CephalexinCephalexinCronus Pharma LLCANDACurrent
70518-3066CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-3066CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-3066CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-3066CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70934-109CephalexinCephalexinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-109CephalexinCephalexinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
72287-310CephalexinCephalexinAMELLA PHARMA, LLCANDACurrent
76413-142CephalexinCephalexinCentral Texas Community Health CentersANDACurrent
80425-0004CephalexinCephalexinADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0004CephalexinCephalexinADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent