Home NDC 64679-922 Cefuroxime Axetil
Product NDC 64679-922
11-digit product format 646790922
Labeler code 64679
Product ID 64679-922_46ecfa55-090f-42a2-9671-a7028c3521fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefuroxime Axetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA065166
Marketing category ANDA
Marketing start 2005-07-29
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 2020-12-31
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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-922-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-922-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-922-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-922-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-922-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-922-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-922-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-922-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-922-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-922-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-922-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-922-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-922-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-922-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-922-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-922-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-922-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-922-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-922-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-922-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-922-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-922-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-922-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64679-922-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64679-922-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64679-922-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64679-922-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64679-922-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64679-922-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64679-922-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065166-001 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 A065166-002 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 A065166-003 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 126 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 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFUROXIME AXETIL ACTIVE INGREDIENT Z49QDT0J8Z CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 CEFUROXIME AXETIL ACTIVE INGREDIENT Z49QDT0J8Z CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 CEFUROXIME ACTIVE MOIETY O1R9FJ93ED CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 CEFUROXIME ACTIVE MOIETY O1R9FJ93ED CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 SMCC INACTIVE INGREDIENT B357P1G1IF CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 SMCC INACTIVE INGREDIENT B357P1G1IF CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFUROXIME AXETIL TABLET, FILM COATED [STAT RX USA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT USA LLC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64679-922-01 64679092201 20 TABLET, FILM COATED in 1 BOTTLE (64679-922-01) 2005-07-29 0000-00-00 No No Current 64679-922-02 64679092202 60 TABLET, FILM COATED in 1 BOTTLE (64679-922-02) 2005-07-29 0000-00-00 No No Current