Cephalexin

Product NDC
67296-1211
Requested package NDC
67296-1211-7
11-digit product format
672961211
Labeler code
67296
Product ID
67296-1211_9c9f179f-87f0-0a99-e053-2995a90a4eba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA062713
Marketing category
ANDA
Marketing start
2015-06-02
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 packagepackage67296-121167296-1211-7IInactivated by FDA2026-08-17

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 42.

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
A062713-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15
A062713-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062713-001AB
A062713-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A062713-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062713-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062713-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062713-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062713-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062713-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062713-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062713-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062713-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062713-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062713-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062713-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062713-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062713-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062713-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062713-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062713-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062713-002AB1bb7c543d1eb4…

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
67296-1211-1Cephalexin14 in 1 BOTTLECAPSULE144
67296-1211-2Cephalexin20 in 1 BOTTLECAPSULE204
67296-1211-3Cephalexin30 in 1 BOTTLECAPSULE304
67296-1211-4Cephalexin40 in 1 BOTTLECAPSULE404
67296-1211-5Cephalexin15 in 1 BOTTLECAPSULE154
67296-1211-6Cephalexin28 in 1 BOTTLECAPSULE284
67296-1211-7Cephalexin10 in 1 BOTTLECAPSULE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1211CEPHALEXIN CAPSULE [REDPHARM DRUG, INC.]4Legacy NDC, 7 package rows20200121_4f1bf27a-e9d7-347b-e054-00144ff88e88.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINAvKARE03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062713
application number: ANDA062713

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN4f1bf27a-e9d7-347b-e054-00144ff88e884
309114cephalexin 500 MG Oral CapsuleSCD4f1bf27a-e9d7-347b-e054-00144ff88e884
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY4f1bf27a-e9d7-347b-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1211-76729612110710 CAPSULE in 1 BOTTLE (67296-1211-7) 10 capsule2015-06-020000-00-00NoNoCurrent