FDA.reportPublic FDA data

cefuroxime axetil

Product NDC
68788-9701
11-digit product format
687889701
Labeler code
68788
Product ID
68788-9701_369bde7a-952c-483c-a667-117ecd4d6153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefuroxime axetil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065135
Marketing category
ANDA
Marketing start
2013-03-15
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9701DDiscontinued by firm2026-07-31
excluded packagepackage68788-970168788-9701-2DDiscontinued by firm2026-07-31
excluded packagepackage68788-970168788-9701-3DDiscontinued by firm2026-07-31
excluded packagepackage68788-970168788-9701-6DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065135-001CEFUROXIME AXETILCEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25
A065135-002CEFUROXIME AXETILCEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25a50c72e98297…
2026-08-01 22:54:322026-06A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25a50c72e98297…