Cephalexin

Product NDC
68788-9404
11-digit product format
687889404
Labeler code
68788
Product ID
68788-9404_5de88b3e-7ea8-4f65-a7ae-1242f8a7ccd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2014-05-28
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9404DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-1DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-2DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-3DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-4DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-5DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-6DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-7DDiscontinued by firm2026-08-11
excluded packagepackage68788-940468788-9404-8DDiscontinued by firm2026-08-11

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 2 · 108 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 packagepackage68788-9404-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9404-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9404-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9404-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9404-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9404-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9404-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9404-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9404-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9404-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9404-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9404-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9404-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9404-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9404-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9404-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9404-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9404-3302b2466d912…e7b80fea0513…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065253-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16
A065253-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16
A065253-003CEPHALEXINCEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065253-001AB
A065253-002AB
A065253-003AB

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 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001AB18072bd15b7f6…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]3

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.2506895d-f3e0-4be9-95cb-7a6fd44de46d2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.88426cb3-1c0c-439b-9f1a-aa169040c29f2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNorthwind Health Company, LLC1d0d50ba-8c2c-855c-e063-6394a90a5c7d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack47b6bc70-e8cc-4837-a39a-6998ee4e37dc2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack8a938dd0-fca6-4f22-9fb0-6325966030012026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.52d8a080-eafc-46fe-82d9-6b69c6a3a38a2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINChartwell RX, LLCd315cce8-9784-419e-818b-16d68d1dbd6e2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0b3da88f-f513-cdf0-e063-6394a90a72052025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack2070b988-f7fb-4e35-91e3-1b7df5e5326c2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINAMELLA PHARMA, LLC602fae70-3b8a-4f09-8db1-41fef4a2ecd72025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINREMEDYREPACK INC.c0ca008e-0e28-412e-a58f-70f63817713b2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf3b46058-3e53-413b-b9c9-7d49e50f861e2025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack88a744d8-a95e-4c63-8b25-52f5039b6ba12025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0aad51b4-86d5-e312-e063-6394a90a250d2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack50f0187b-09e7-4c11-970f-91cd1877fde12025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack905b3270-abbd-4d5c-b313-3d20eb4b4c572025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf2e73727-2ab6-4418-9677-19ea1d140bbd2025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINCoupler, LLC30b7071e-cef1-bd41-e063-6394a90ad48e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals, Inc.28da5822-fb0b-1306-e063-6394a90a6e4c2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINA-S Medication Solutions02b5cd6f-3df8-43c1-879d-217fcf55231a2025-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9404-16878894040112 CAPSULE in 1 BOTTLE (68788-9404-1) 12 capsule2014-05-280000-00-00NoNoCurrent
68788-9404-26878894040220 CAPSULE in 1 BOTTLE (68788-9404-2) 20 capsule2014-05-280000-00-00NoNoCurrent
68788-9404-36878894040330 CAPSULE in 1 BOTTLE (68788-9404-3) 30 capsule2014-05-280000-00-00NoNoCurrent
68788-9404-46878894040440 CAPSULE in 1 BOTTLE (68788-9404-4) 40 capsule2014-05-280000-00-00NoNoCurrent
68788-9404-5687889404056 CAPSULE in 1 BOTTLE (68788-9404-5) 6 capsule2014-05-280000-00-00NoNoCurrent
68788-9404-66878894040660 CAPSULE in 1 BOTTLE (68788-9404-6) 60 capsule2014-05-280000-00-00NoNoCurrent
68788-9404-76878894040721 CAPSULE in 1 BOTTLE (68788-9404-7) 21 capsule2014-05-280000-00-00NoNoCurrent
68788-9404-86878894040828 CAPSULE in 1 BOTTLE (68788-9404-8) 28 capsule2014-05-280000-00-00NoNoCurrent