cephalexin

Product NDC
67296-1292
Requested package NDC
67296-1292-5
11-digit product format
672961292
Labeler code
67296
Product ID
67296-1292_9c9f47b5-91a1-71a4-e053-2995a90ac59d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065248
Marketing category
ANDA
Marketing start
2008-01-18
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-129267296-1292-5IInactivated 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 1 · 19 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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…

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
67296-1292-1cephalexin10 in 1 BOTTLECAPSULE102
67296-1292-2cephalexin20 in 1 BOTTLECAPSULE202
67296-1292-3cephalexin30 in 1 BOTTLECAPSULE302
67296-1292-4cephalexin40 in 1 BOTTLECAPSULE402
67296-1292-5cephalexin15 in 1 BOTTLECAPSULE152
67296-1292-6cephalexin14 in 1 BOTTLECAPSULE142
67296-1292-7cephalexin28 in 1 BOTTLECAPSULE282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1292CEPHALEXIN CAPSULE [REDPHARM DRUG, INC.]2Legacy NDC, 7 package rows20200121_4fcf1f87-772b-1cbb-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN4fcf1f87-772b-1cbb-e054-00144ff88e882
309114cephalexin 500 MG Oral CapsuleSCD4fcf1f87-772b-1cbb-e054-00144ff88e882
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY4fcf1f87-772b-1cbb-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1292-56729612920515 CAPSULE in 1 BOTTLE (67296-1292-5) 15 capsule2008-01-180000-00-00NoNoCurrent