Cephalexin

Product NDC
64205-101
11-digit product format
642050101
Labeler code
64205
Product ID
64205-101_d1008381-21e1-4097-bb77-df25a38145e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
ReadyMeds
Application
ANDA062713
Marketing category
ANDA
Marketing start
2012-01-12
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64205-101IInactivated by FDA2026-08-17
excluded packagepackage64205-10164205-101-14IInactivated 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 · 44 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 packagepackage64205-101-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64205-101-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64205-101-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64205-101-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64205-101-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64205-101-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64205-101-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64205-101-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64205-101-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64205-101-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64205-101-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64205-101-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64205-101-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64205-101-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64205-101-141332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64205-101-14fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64205-101-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64205-101-14bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64205-101-148dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64205-101-14e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64205-101-149bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64205-101-14110d247fa046…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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64205-101-142019-11-27C16284748780-19855e2a2-3306-60a7-e053-dbdaa90a05bdCEPHALEXIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-101-14Cephalexin14 in 1 BOTTLECAPSULE146

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [READYMEDS]6
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [READYMEDS]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [READYMEDS]6
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [READYMEDS]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [READYMEDS]6
TALCINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [READYMEDS]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [READYMEDS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-101CEPHALEXIN CAPSULE [READYMEDS]6Legacy NDC, 1 package rows20140505_a3ac2ea9-1346-4e65-a711-38cbd83c2635.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
309112cephalexin 250 MG Oral CapsulePSNa3ac2ea9-1346-4e65-a711-38cbd83c26356
309114cephalexin 500 MG Oral CapsulePSNa3ac2ea9-1346-4e65-a711-38cbd83c26356
309112cephalexin 250 MG Oral CapsuleSCDa3ac2ea9-1346-4e65-a711-38cbd83c26356
309114cephalexin 500 MG Oral CapsuleSCDa3ac2ea9-1346-4e65-a711-38cbd83c26356
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYa3ac2ea9-1346-4e65-a711-38cbd83c26356
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYa3ac2ea9-1346-4e65-a711-38cbd83c26356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-101-146420501011414 in 1 BOTTLEHistorical