FDA.reportPublic FDA data

cefuroxime axetil

Product NDC
60429-657
11-digit product format
604290657
Labeler code
60429
Product ID
60429-657_c8479f14-713f-166a-e053-2995a90a224a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefuroxime axetil
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60429-657DDiscontinued by firm2026-07-31
excluded packagepackage60429-65760429-657-20DDiscontinued by firm2026-07-31
excluded packagepackage60429-65760429-657-60DDiscontinued 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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-657-20EA - Each60429-6579a973d74-750a-491f-bb6a-2ff29b384e2712016-07-19
60429-657-60EA - Each60429-657487d202e-648d-4fbf-8723-18d155e518ef12016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-657-206042906572020 TABLET in 1 BOTTLE (60429-657-20) 20 tablet2016-02-220000-00-00NoNoCurrent
60429-657-606042906576060 TABLET in 1 BOTTLE (60429-657-60) 60 tablet2016-02-220000-00-00NoNoCurrent