Cephalexin

Product NDC
68071-2726
11-digit product format
680712726
Labeler code
68071
Product ID
68071-2726_dfafc221-3446-71a1-e053-2a95a90a6301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2726IInactivated by FDA2026-08-10
excluded packagepackage68071-272668071-2726-4IInactivated by FDA2026-08-10
excluded packagepackage68071-272668071-2726-6IInactivated by FDA2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2726-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2726-4IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2726-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2726-4IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2726-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2726-4IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2726-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2726-4IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2726-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2726-4IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2726-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2726-4IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2726-6UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2726-4UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2726-6UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2726-4UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2726-6UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2726-4UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2726-4Cephalexin4 in 1 BOTTLECAPSULE42
68071-2726-6Cephalexin6 in 1 BOTTLECAPSULE62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2726CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230803_dfafbc14-da81-4878-e053-2995a90a0358.zip

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
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
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
CephalexinCEPHALEXINQPharma Inc4e9a8ed3-c490-4a0e-bb29-5eea506f893b2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.6ce11859-aa21-4b3f-bd59-3cd26deca82b2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
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
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
CephalexinCEPHALEXINTeva Pharmaceuticals USA, Inc.19307ff0-71de-477b-965d-ea243e5ede3a2020-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNdfafbc14-da81-4878-e053-2995a90a03582
309114cephalexin 500 MG Oral CapsuleSCDdfafbc14-da81-4878-e053-2995a90a03582
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYdfafbc14-da81-4878-e053-2995a90a03582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2726-4680712726044 in 1 BOTTLEHistorical
68071-2726-6680712726066 CAPSULE in 1 BOTTLE (68071-2726-6) 6 capsule2022-05-230000-00-00NoNoCurrent