Home NDC 68180-303-20 cefuroxime axetil
Product NDC 68180-303
Requested package NDC 68180-303-20
11-digit product format 681800303
Labeler code 68180
Product ID 68180-303_6def7bcd-63fa-47aa-88dd-f7073d3d1fc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefuroxime axetil
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065135
Marketing category ANDA
Marketing start 2008-10-08
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 2022-12-31
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 · 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.
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 A065135-001 CEFUROXIME AXETIL EQ 250MG BASE TABLET / ORAL 2003-07-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A065135-002 CEFUROXIME AXETIL EQ 500MG BASE TABLET / ORAL 2003-07-25 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFUROXIME AXETIL ACTIVE INGREDIENT Z49QDT0J8Z CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 CEFUROXIME ACTIVE MOIETY O1R9FJ93ED CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFUROXIME AXETIL TABLET [LUPIN PHARMACEUTICALS, INC.] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-303-20 68180030320 20 TABLET in 1 BOTTLE (68180-303-20) 20 tablet 2008-10-08 0000-00-00 No No Current