Application 065248

Type
ANDA
Sponsor
ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINCAPSULE;ORALEQ 250MG BASENoNo
002CEPHALEXINCEPHALEXINCAPSULE;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
A065248-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28
A065248-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065248-001AB
A065248-002AB

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 22:38:342026-08A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2884e616aacf4f…
2026-08-18 06:07:402026-07A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-2874a2ff9319b5…

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 22:38:342026-08A065248-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065248-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065248-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065248-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065248-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065248-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065248-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065248-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065248-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065248-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065248-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065248-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065248-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065248-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065248-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065248-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065248-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065248-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065248-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065248-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065248-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065248-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065248-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065248-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065248-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065248-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065248-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065248-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065248-002AB174a2ff9319b5…

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 4 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.6ce11859-aa21-4b3f-bd59-3cd26deca82b2025-11-07Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack5f867aa3-ea64-4a14-a63b-979b8ff8d80c2025-11-07Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack2070b988-f7fb-4e35-91e3-1b7df5e5326c2025-11-06Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINAvPAK5975f293-8bb3-3242-aca7-d7d0c7e1bdc82025-10-30Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINA-S Medication Solutions21392758-c033-4d4d-81c9-d10e132f95b72025-10-18Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINA-S Medication Solutionsbff3912c-c39c-40c0-98d2-27c3d506c24d2025-10-18Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINAMELLA PHARMA, LLC602fae70-3b8a-4f09-8db1-41fef4a2ecd72025-10-10Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepackf3b46058-3e53-413b-b9c9-7d49e50f861e2025-09-26Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack88a744d8-a95e-4c63-8b25-52f5039b6ba12025-09-17Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack8d7f247a-3b42-4823-96fb-5f5c1bd94d492025-08-29Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack1bfa8744-24ee-4c70-845c-c532b80844332025-07-29Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0aad51b4-86d5-e312-e063-6394a90a250d2025-07-08Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack50f0187b-09e7-4c11-970f-91cd1877fde12025-06-03Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack905b3270-abbd-4d5c-b313-3d20eb4b4c572025-06-03Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepackf2e73727-2ab6-4418-9677-19ea1d140bbd2025-06-03Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINCoupler, LLC30b7071e-cef1-bd41-e063-6394a90ad48e2025-03-19Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINNuCare Pharmaceuticals, Inc.28da5822-fb0b-1306-e063-6394a90a6e4c2025-03-19Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINA-S Medication Solutions02b5cd6f-3df8-43c1-879d-217fcf55231a2025-02-11Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack12f78d76-ea13-440c-8dd0-5aec86277acf2025-01-24Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINCronus Pharma LLCa4e861e2-5803-4c4a-a962-92f5755e1ab52025-01-10Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN

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 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-503CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
12634-434cephalexincephalexinApotheca Inc.ANDACurrent
42043-140cephalexincephalexinOrchidPharma IncANDACurrent
42043-140cephalexincephalexinOrchidPharma IncANDACurrent
42043-141cephalexincephalexinOrchidPharma IncANDACurrent
42043-141cephalexincephalexinOrchidPharma IncANDACurrent
49364-110CephalexinCephalexinStrategic Pharmaceutical Solutions, Inc. DBA VetSourceANDACurrent
49364-111CephalexinCephalexinStrategic Pharmaceutical Solutions, Inc. DBA VetSourceANDACurrent
51655-720CephalexinCephalexinNorthwind PharmaceuticalsANDACurrent
61919-035CEPHALEXINCEPHALEXINDIRECT RXANDACurrent
61919-035CEPHALEXINCEPHALEXINDirect_RxANDACurrent
61919-035CEPHALEXINCEPHALEXINDirect_RxANDACurrent
61919-410KEFLEXCEPHALEXINDIRECT RXANDACurrent
63187-592cephalexincephalexinProficient Rx LPANDACurrent
63187-699cephalexincephalexinProficient Rx LPANDACurrent
63629-7605cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7606cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7607cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7618cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7618cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7628cephalexincephalexinBryant Ranch PrepackANDACurrent
63629-7630cephalexincephalexinBryant Ranch PrepackANDACurrent
66116-388cephalexincephalexinMedVantx, Inc.ANDACurrent
66267-049cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-049cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-050cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-050cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-769cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-769cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-770cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-770cephalexincephalexinNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1292cephalexincephalexinRedPharm Drug, Inc.ANDACurrent
67296-1292cephalexincephalexinRedPharm Drug, Inc.ANDACurrent
68788-9950cephalexincephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9951cephalexincephalexinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0826CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-0826CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-0912cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-0912cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-0957CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-0957CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-1148cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-1148cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-1379cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70518-1379cephalexincephalexinREMEDYREPACK INC.ANDACurrent
70934-034cephalexincephalexinDenton Pharma, Inc.ANDACurrent
70934-037cephalexincephalexinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
76420-035cephalexincephalexinAsclemed USA, Inc.ANDACurrent