Cefuroxime Axetil

Product NDC: 55289-385
11-digit product format: 552890385
Labeler code: 55289
Product ID: 55289-385_d2908a67-9891-3749-e053-2a95a90a2591
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefuroxime Axetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065166
Marketing category: ANDA
Marketing start: 2005-07-29
Marketing end: 0000-00-00
Substance: CEFUROXIME AXETIL
Active strength: 250 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.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55289-385		D	Discontinued by firm	2026-07-31
excluded package	package	55289-385	55289-385-04	D	Discontinued by firm	2026-07-31
excluded package	package	55289-385	55289-385-30	D	Discontinued by firm	2026-07-31

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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-385-04	EA - Each	55289-385	0c95b825-1e0f-4d2d-8321-0c9dc1c00503	1	2012-07-24
55289-385-30	EA - Each	55289-385	ad1c5b7a-d233-4704-8731-b662052a8def	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFUROXIME AXETIL	ACTIVE INGREDIENT	Z49QDT0J8Z	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
CEFUROXIME	ACTIVE MOIETY	O1R9FJ93ED	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
SMCC	INACTIVE INGREDIENT	B357P1G1IF	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z49QDT0J8Z	CEFUROXIME AXETIL	64544-07-6	CEFUROXIME AXETIL

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-385-04	55289038504	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-385-04)	2012-02-02	0000-00-00	No	No	Current
55289-385-30	55289038530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-385-30)	2012-02-02	0000-00-00	No	No	Current