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 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
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 · 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 UTC2026-02A065248-001CEPHALEXINEQ 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…
2022-03-09 01:35 UTC2022-03A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065248-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-06-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A065248-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-06-28782e0a99824c…

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 UTC2026-02A065248-001AB1011fe1cb6892…
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…
2022-03-09 01:35 UTC2022-03A065248-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065248-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065248-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065248-002AB1782e0a99824c…

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 8 · 155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINAvKARE03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d2026-07-29Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.88426cb3-1c0c-439b-9f1a-aa169040c29f2026-07-23Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINREMEDYREPACK INC.a6b5edf2-1ef8-46b7-977a-8c303900f3f02026-07-22Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINAurobindo Pharma Limited655f38e8-1c4d-4cbc-9f52-bb881f065b2d2026-07-21Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack0384c418-b4d4-4c06-9ed9-13e864b1980b2026-07-16Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepackd6954168-9c7f-4a6c-9262-2e6bed5c9f242026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack7508351d-69fe-457c-b450-9a2343be25872026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack980b9dd9-cb61-4c4f-81ac-85ee5a7c24972026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack759c3856-8d3a-4036-926c-8508b573c7362026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack5b9b212a-3a3e-4637-b23c-6d66d8cf11712026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack11cfefee-d75e-430c-8817-02dc57de0e882026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepack43ca66ae-2ada-412d-bc5d-f53602f535a52026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINBryant Ranch Prepackcf1c5d03-eddc-463a-84ad-4d59362c2cf82026-07-14Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINHAWAII REPACK, INC.d54abc0a-3c8f-4f02-bd55-406f0c5b925a2026-07-13Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINNorthwind Health Company, LLC1d0d50ba-8c2c-855c-e063-6394a90a5c7d2026-07-09Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINNorthwind Health Company, LLC4ecf9314-76e2-c270-e063-6294a90ad8db2026-07-09Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.e54df878-c235-4aa3-af33-fe5287c731382026-06-18Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINAscend Laboratories, LLC4fec8daf-6e09-4153-926f-64709dbdd26c2026-06-17Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINREMEDYREPACK INC.b3bb8222-161e-4d9c-8e08-7e22ad65bf722026-06-16Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN
CephalexinCEPHALEXINREMEDYREPACK INC.8499aa5a-49b1-4555-bd27-6177d92b261d2026-06-09Warnings, Adverse reactionsName fallback
brand name: Cephalexin
generic name: CEPHALEXIN

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