Cephalexin

Product NDC
63187-287
11-digit product format
631870287
Labeler code
63187
Product ID
63187-287_c6d27efc-fc18-487c-844f-b44e47b42b2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
No
Listing certified through
2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-287DDiscontinued by firm2026-08-17
excluded packagepackage63187-28763187-287-20DDiscontinued by firm2026-08-17
excluded packagepackage63187-28763187-287-28DDiscontinued by firm2026-08-17
excluded packagepackage63187-28763187-287-30DDiscontinued by firm2026-08-17
excluded packagepackage63187-28763187-287-40DDiscontinued by firm2026-08-17

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 · 60 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 packagepackage63187-287-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-287-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-287-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-287-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-287-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-287-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-287-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-287-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-287-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-287-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-287-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-287-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-287-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-287-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-287-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-287-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-287-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-287-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-287-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-287-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-287-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-287-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-287-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-287-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-287-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-287-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-287-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-287-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-287-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-287-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-287-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-287-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-287-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-287-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-287-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-287-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-287-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-287-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-287-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-287-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-287-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-287-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-287-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-287-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-287-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-287-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-287-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-287-28557ba5c1ecfa…9c80585c8c6e…

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PROFICIENT RX LP]2

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