Application 062702

Type
ANDA
Sponsor
TEVA

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
A062702-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13
A062702-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062702-001AB
A062702-002AB

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 UTC2026-02A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13782e0a99824c…

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 UTC2026-02A062702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062702-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062702-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062702-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062702-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062702-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062702-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062702-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062702-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062702-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062702-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062702-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062702-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062702-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062702-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062702-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062702-002AB1782e0a99824c…

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.b73593ce-0b1f-4371-bae1-140742de3b422026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 70518-3362
CephalexinCEPHALEXINUnit Dose Solutions, Inc.53704ffd-b4f6-8b61-e063-6394a90a01f92026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.ad676021-44f3-4a97-a3dc-28a62fe982bb2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.3fed2817-fc0d-43cd-9f02-948fbc76672c2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 55289-057
CephalexinCEPHALEXINAVKARE74f83298-57f7-4166-8dd8-db3e556a68d82025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINQPharma Ince8b3ece4-cf73-416c-8767-68f425df35f82025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 42708-017
CephalexinCEPHALEXINQPharma Inc4e9a8ed3-c490-4a0e-bb29-5eea506f893b2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 42708-100
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.6ce11859-aa21-4b3f-bd59-3cd26deca82b2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 55289-058
CephalexinCEPHALEXINA-S Medication Solutionsbff3912c-c39c-40c0-98d2-27c3d506c24d2025-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ade02343-3e4b-b1f1-e053-2995a90ac5fe2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 68071-2249
CephalexinCEPHALEXINA-S Medication Solutionsfc426d0d-9774-4189-8d83-89aa85d926bb2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINA-S Medication Solutions5b7666f3-4014-45ce-8387-3298d9fe6d252024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINBryant Ranch Prepack18518154-30ba-48a4-852a-3a77230300712023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINProficient Rx LPada7b8a5-98f4-454c-b38f-92192d4db33f2021-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 71205-591
CephalexinCEPHALEXINTeva Pharmaceuticals USA, Inc.19307ff0-71de-477b-965d-ea243e5ede3a2020-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 0093-3145
ndc (product): 0093-3147

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3145CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3145CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3145CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3145CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3145CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3145CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3147CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3147CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3147CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3147CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3147CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3147CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-020CephalexinCephalexinBlenheim Pharmacal, Inc.ANDACurrent
42708-017CephalexinCephalexinQPharma IncANDACurrent
42708-017CephalexinCephalexinQPharma IncANDACurrent
42708-017CephalexinCephalexinQPharma IncANDACurrent
42708-100CephalexinCephalexinQPharma IncANDACurrent
42708-100CephalexinCephalexinQPharma IncANDACurrent
50090-4423CephalexinCephalexinA-S Medication SolutionsANDACurrent
53002-2181CephalexinCephalexinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2181CephalexinCephalexinRPK Pharmaceuticals, Inc.ANDACurrent
53217-207CephalexinCephalexinAidarex Pharmaceuticals LLCANDACurrent
53217-299CephalexinCephalexinAidarex Pharmaceuticals LLCANDACurrent
53808-0222CephalexinCEPHALEXINState of Florida DOH Central PharmacyANDACurrent
55289-057CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-057CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-057CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-057CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-057CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-057CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-058CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-058CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-058CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-058CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-058CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-058CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-058CephalexinCephalexinPD-Rx Pharmaceuticals, Inc.ANDACurrent
66116-255CephalexinCephalexinMedVantx, Inc.ANDACurrent
67296-0037CephalexinCephalexinRedPharm Drug, Inc.ANDACurrent
67296-0037CephalexinCephalexinRedPharm Drug, Inc.ANDACurrent
68071-2249CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2249CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2726CephalexinCephalexinNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3362CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
70518-3595CephalexinCephalexinREMEDYREPACK INC.ANDACurrent
71205-591CephalexinCephalexinProficient Rx LPANDACurrent