Home NDC 64679-922-02 Cefuroxime Axetil
Product NDC 64679-922
Requested package NDC 64679-922-02
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 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-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.
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 2026-08-01 22:54:32 2026-06 A065166-001 CEFUROXIME AXETIL EQ 125MG BASE TABLET / ORAL AB 2005-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A065166-002 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL AB 2005-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A065166-003 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL AB 2005-07-29 a50c72e98297…
Observed Orange Book normalized TE history# 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 64679-922-02 64679092202 60 TABLET, FILM COATED in 1 BOTTLE (64679-922-02) 2005-07-29 0000-00-00 No No Current