Cephalexin

Product NDC
52959-030
11-digit product format
529590030
Labeler code
52959
Product ID
52959-030_87894a01-9fab-4362-b6d4-f9a5f6a88d0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2005-12-01
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-030IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-01IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-08IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-12IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-20IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-24IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-28IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-30IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-40IInactivated by FDA2026-08-10
excluded packagepackage52959-03052959-030-56IInactivated by FDA2026-08-10

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 4 · 220 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 packagepackage52959-030-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-56d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-030-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-56f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-030-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-562ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-030-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-030-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-56cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-030-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-56cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-030-24cdf11ea48f46…ba0047e9e063…

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
A065229-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25
A065229-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065229-001AB
A065229-002AB

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 UTC2026-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…

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 UTC2026-02A065229-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002AB1782e0a99824c…

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
52959-030-01Cephalexin100 in 1 BOTTLECAPSULE1003
52959-030-08Cephalexin8 in 1 BOTTLECAPSULE83
52959-030-12Cephalexin12 in 1 BOTTLECAPSULE123
52959-030-20Cephalexin20 in 1 BOTTLECAPSULE203
52959-030-24Cephalexin24 in 1 BOTTLECAPSULE243
52959-030-28Cephalexin28 in 1 BOTTLECAPSULE283
52959-030-30Cephalexin30 in 1 BOTTLECAPSULE303
52959-030-40Cephalexin40 in 1 BOTTLECAPSULE403
52959-030-56Cephalexin56 in 1 BOTTLECAPSULE563

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-030-01EA - Each52959-030f5127944-b352-4d18-94de-a5aef2b0c84e12012-07-24
52959-030-08EA - Each52959-030c32bc9b9-1ee4-403b-b59c-aae901b4ac0d12012-07-24
52959-030-12EA - Each52959-0309b717d56-b9c5-4fec-92ed-37b48d57db8812012-07-24
52959-030-20EA - Each52959-03059b25fa0-e701-44dc-9bc6-1b8cf49413b112012-07-24
52959-030-24EA - Each52959-030258b088b-e311-4c11-a558-72da07a609af12012-07-24
52959-030-28EA - Each52959-0306c6bd164-1dd0-4f7c-a712-300a53bf519612012-07-24
52959-030-30EA - Each52959-03091a29423-07d6-4443-b13a-0d669dbf08df12012-07-24
52959-030-40EA - Each52959-0308c22059d-1c58-4f68-837d-b902d89c6fa412012-07-24
52959-030-56EA - Each52959-03034abba2e-0bfa-42cb-bf90-aeb8c099d74012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-030CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 9 package rows20120120_c5f1a7f6-a5a4-48f1-9022-d6d402bfd349.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.b3bb8222-161e-4d9c-8e08-7e22ad65bf722026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINREMEDYREPACK INC.8499aa5a-49b1-4555-bd27-6177d92b261d2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINCoupler LLC508a3401-df0b-0555-e063-6294a90a155a2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINSportpharm LLC3d5a2665-65da-4b10-9e23-39fc88145da12026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.13444dc7-7da1-4181-a9ac-d95d4a235e6d2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINLupin Pharmaceuticals, Inc.1d3e6d33-5dc2-498e-8efa-e3c4fca15dff2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf4abf8b-22cc-da58-e053-2a95a90aa7662024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.a33280d4-7caf-f74b-e053-2a95a90a90c32024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc945552cb-90e4-41fb-afe2-8ee8785e94da2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.20f8cc57-231c-4d36-a209-ff9e5735d65c2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.728c5212-dbd8-8df5-e053-2a91aa0a95792024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf10128f-021a-14b7-e053-2a95a90a43652024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.6032b68f-16d8-41b6-bd2c-86d5406a757a2022-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINProficient Rx LPdec3a1ef-1e85-4236-804b-e7a343d3a58f2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSNc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493
309112cephalexin 250 MG Oral CapsuleSCDc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYc5f1a7f6-a5a4-48f1-9022-d6d402bfd3493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-030-0152959003001100 in 1 BOTTLEHistorical
52959-030-08529590030088 in 1 BOTTLEHistorical
52959-030-125295900301212 in 1 BOTTLEHistorical
52959-030-205295900302020 in 1 BOTTLEHistorical
52959-030-245295900302424 in 1 BOTTLEHistorical
52959-030-285295900302828 in 1 BOTTLEHistorical
52959-030-305295900303030 in 1 BOTTLEHistorical
52959-030-405295900304040 in 1 BOTTLEHistorical
52959-030-565295900305656 in 1 BOTTLEHistorical