Clozaril

Product NDC: 69809-0135
11-digit product format: 698090135
Labeler code: 69809
Product ID: 69809-0135_c9536339-ee33-4a5f-95fc-80cbb5e048a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clozapine
Dosage form: TABLET
Route: ORAL
Labeler: HLS Therapeutics (USA), Inc.
Application: NDA019758
Marketing category: NDA
Marketing start: 2019-12-17
Marketing end: 0000-00-00
Substance: CLOZAPINE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69809-0135-5	2020-07-22	C162847	48780-1	ab0e2407-3629-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL ® (clozapine) tablets, for oral use Initial U.S. Approval: 1989

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69809-0135-5	EA - Each	69809-0135	5a6f2125-22f0-4bc1-abd8-799acdbdc1ad	1	2020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69809-0135-5	69809013505	100 TABLET in 1 BOTTLE (69809-0135-5)	100 tablet	2019-12-17	0000-00-00	No	No	Current