Home NDC 49999-785 cefuroxime axetil
Product NDC 49999-785
11-digit product format 499990785
Labeler code 49999
Product ID 49999-785_55b09832-cae7-497a-bcfb-eee4d5b65857
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefuroxime axetil
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA065135
Marketing category ANDA
Marketing start 2003-07-25
Marketing end 0000-00-00
Substance CEFUROXIME AXETIL
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49999-785-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49999-785-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49999-785-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49999-785-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49999-785-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49999-785-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49999-785-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49999-785-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49999-785-20 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49999-785-20 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49999-785-20 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49999-785-20 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065135-001 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2003-07-25 A065135-002 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2003-07-25
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2003-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2003-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2003-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2003-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2003-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2003-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2003-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB RS 2003-07-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.