CEFACLOR

Product NDC: 0143-9986
11-digit product format: 001439986
Labeler code: 0143
Product ID: 0143-9986_79869725-288c-4691-a0d3-8d02b7caf510
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFACLOR
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA065350
Marketing category: ANDA
Marketing start: 2007-05-01
Marketing end: 0000-00-00
Substance: CEFACLOR
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	0143-9986		D	Discontinued by firm	2026-07-31
excluded package	package	0143-9986	0143-9986-01	D	Discontinued by firm	2026-07-31
excluded package	package	0143-9986	0143-9986-15	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
A065350-001	CEFACLOR	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2007-04-03
A065350-002	CEFACLOR	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL			2007-04-03

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9986-01	EA - Each	0143-9986	23450ed2-6803-4dde-8833-c282f9cfc8cb	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFACLOR	ACTIVE INGREDIENT	69K7K19H4L	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
CEFACLOR ANHYDROUS	ACTIVE MOIETY	3Z6FS3IK0K	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFACLOR CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	11

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69K7K19H4L	CEFACLOR	70356-03-5	CEFACLOR

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9986-01	00143998601	100 CAPSULE in 1 BOTTLE (0143-9986-01)	100 capsule	2007-05-01	0000-00-00	No	No	Current
0143-9986-15	00143998615	15 CAPSULE in 1 BOTTLE (0143-9986-15)	15 capsule	2007-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFACLOR CAPSULES, USP Rev. 11/2020 Rx Only	Hikma Pharmaceuticals USA Inc. \| Al Jazeera for Pharmaceuticals Industries	2020-11-18	HUMAN PRESCRIPTION DRUG LABEL	13
Cefaclor	A-S Medication Solutions	2018-08-31	HUMAN PRESCRIPTION DRUG LABEL	8