Cefuroxime Axetil

Product NDC: 68788-9333
11-digit product format: 687889333
Labeler code: 68788
Product ID: 68788-9333_1db947ad-40da-4934-a66b-697be4a00ea9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefuroxime Axetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA065166
Marketing category: ANDA
Marketing start: 2014-09-18
Marketing end: 0000-00-00
Substance: CEFUROXIME AXETIL
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9333		D	Discontinued by firm	2026-07-31
excluded package	package	68788-9333	68788-9333-2	D	Discontinued by firm	2026-07-31
excluded package	package	68788-9333	68788-9333-3	D	Discontinued by firm	2026-07-31
excluded package	package	68788-9333	68788-9333-6	D	Discontinued by firm	2026-07-31

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	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.

Application-product, TE code table
Application-product	TE code
A065166-001	AB
A065166-002	AB
A065166-003	AB

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A065166-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065166-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065166-003	AB	1	`a50c72e98297…`