Cephalexin

Product NDC
68289-008
11-digit product format
682890008
Labeler code
68289
Product ID
68289-008_24fc53ef-d9ef-401a-8bbe-3fc0d76a6cf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Jazeera Pharmaceutical
Application
ANDA065444
Marketing category
ANDA
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
CEPHALEXIN ANHYDROUS
Active strength
125 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct68289-008IInactivated by FDA2026-08-03
excluded packagepackage68289-00868289-008-01IInactivated by FDA2026-08-03
excluded packagepackage68289-00868289-008-20IInactivated by FDA2026-08-03

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68289-008-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68289-008-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68289-008-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68289-008-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68289-008-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68289-008-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68289-008-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68289-008-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68289-008-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68289-008-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68289-008-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68289-008-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68289-008-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68289-008-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68289-008-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68289-008-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68289-008-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68289-008-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68289-008-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68289-008-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68289-008-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68289-008-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68289-008-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68289-008-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68289-008-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68289-008-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68289-008-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68289-008-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68289-008-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68289-008-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68289-008-01fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68289-008-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68289-008-0186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68289-008-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68289-008-01bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68289-008-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68289-008-018dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68289-008-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68289-008-01e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68289-008-20e2bbac7714bc…27bdfed8d636…

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
A065444-001CEPHALEXINCEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28
A065444-002CEPHALEXINCEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28

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 UTC2026-02A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065444-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A065444-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2009-08-28782e0a99824c…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68289-008-012019-10-21C16284748780-1956f9ecf-c2d6-621f-e053-dbdaa90a74adCephalexin for Oral Suspension USP
68289-008-202019-10-21C16284748780-1956f9ecf-c2d6-621f-e053-dbdaa90a74adCephalexin for Oral Suspension USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68289-008-01CephalexinUSP100 mL in 1 BOTTLESUSPENSION1002
68289-008-20CephalexinUSP200 mL in 1 BOTTLESUSPENSION2002

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68289-008CEPHALEXIN USP (CEPHALEXIN) SUSPENSION [JAZEERA PHARMACEUTICAL]2Legacy NDC, 2 package rows20090922_2b388b1e-cd59-42de-ba72-858485b070b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSN2b388b1e-cd59-42de-ba72-858485b070b72
309113cephalexin 250 MG in 5 mL Oral SuspensionPSN2b388b1e-cd59-42de-ba72-858485b070b72
309110cephalexin 25 MG/ML Oral SuspensionSCD2b388b1e-cd59-42de-ba72-858485b070b72
309113cephalexin 50 MG/ML Oral SuspensionSCD2b388b1e-cd59-42de-ba72-858485b070b72
309110cefalexin 25 MG/ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72
309113cefalexin 50 MG/ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72
309110cephalexin 125 MG per 5 ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72
309113cephalexin 250 MG per 5 ML Oral SuspensionSY2b388b1e-cd59-42de-ba72-858485b070b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68289-008-0168289000801100 mL in 1 BOTTLE100 mlHistorical
68289-008-2068289000820200 mL in 1 BOTTLE200 mlHistorical