Cefuroxime Axetil

Product NDC
68788-9333
11-digit product format
687889333
Labeler code
68788
Product ID
68788-9333_1db947ad-40da-4934-a66b-697be4a00ea9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065166
Marketing category
ANDA
Marketing start
2014-09-18
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9333DDiscontinued by firm2026-08-03
excluded packagepackage68788-933368788-9333-2DDiscontinued by firm2026-08-03
excluded packagepackage68788-933368788-9333-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-933368788-9333-6DDiscontinued by firm2026-08-03

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 · 48 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 packagepackage68788-9333-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9333-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9333-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9333-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9333-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9333-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9333-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9333-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9333-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9333-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9333-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9333-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9333-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9333-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9333-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9333-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9333-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9333-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9333-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9333-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9333-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9333-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9333-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9333-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9333-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9333-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9333-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9333-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9333-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9333-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9333-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9333-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9333-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9333-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9333-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9333-6557ba5c1ecfa…9c80585c8c6e…

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
A065166-001CEFUROXIME AXETILCEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-29
A065166-002CEFUROXIME AXETILCEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-29
A065166-003CEFUROXIME AXETILCEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065166-001AB
A065166-002AB
A065166-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065166-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2005-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065166-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2005-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065166-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2005-07-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065166-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065166-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065166-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065166-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065166-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065166-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065166-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065166-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065166-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065166-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065166-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065166-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065166-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065166-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065166-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065166-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065166-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065166-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065166-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065166-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065166-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065166-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065166-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065166-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065166-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065166-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065166-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065166-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065166-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065166-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065166-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065166-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065166-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065166-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065166-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065166-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065166-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065166-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065166-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065166-001AB18072bd15b7f6…