cefuroxime axetil

Product NDC: 43063-584
11-digit product format: 430630584
Labeler code: 43063
Product ID: 43063-584_d60b436c-40a7-27de-e053-2a95a90a557a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefuroxime axetil
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065135
Marketing category: ANDA
Marketing start: 2008-10-08
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: 2023-12-31
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	Reporting period	Source date
excluded product	product	43063-584		D	Discontinued by firm		2026-07-31
excluded package	package	43063-584	43063-584-20	D	Discontinued by firm		2026-07-31

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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-584-20	EA - Each	43063-584	71f0a412-5db1-47d6-87f9-87bdc9d99c72	1	2015-09-10

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFUROXIME AXETIL	ACTIVE INGREDIENT	Z49QDT0J8Z	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CEFUROXIME	ACTIVE MOIETY	O1R9FJ93ED	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]	6

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-584-20	43063058420	20 TABLET in 1 BOTTLE, PLASTIC (43063-584-20)	20 tablet	2014-12-01	0000-00-00	No	No	Current