Clozapine

Product NDC: 60687-426
11-digit product format: 606870426
Labeler code: 60687
Product ID: 60687-426_3de71656-5df7-240a-e063-6294a90a303a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clozapine
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA206433
Marketing category: ANDA
Marketing start: 2019-02-25
Substance: CLOZAPINE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Clozapine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOZAPINE	200 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	J60AR2IKIC
Rxcui	197535, 197536, 309374, 429212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fde12e54-43fa-cc16-3015-4c000a7b8d3e	Product name	5	20250812
0901063f-b37f-4bf1-8be6-1e2a469e57bc	Product name	2	20180209
e01fb60f-a608-2c68-dfdd-23e6433ece68	Product name	5	20180209
7a7f58c4-be43-7e82-4dfc-128bbed4230a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-426-01	Clozapine	100 in 1 BOX, UNIT-DOSE	TABLET	100		7
60687-426-11	Clozapine	1 in 1 BLISTER PACK	TABLET	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-426-01	EA - Each	60687-426	a8f0f181-7bde-45c8-b54d-29239d9d7a6a	1	2019-02-13
60687-426-11	EA - Each	60687-426	d36bdb39-44fe-4751-a5bb-61f69e4741d9	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-426	CLOZAPINE TABLET [AMERICAN HEALTH PACKAGING]	6	Current NDC, Legacy NDC, 2 package rows	20241109_d36c298b-7292-46e0-898f-43d3e11c3cf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197535	cloZAPine 100 MG Oral Tablet	PSN	d36c298b-7292-46e0-898f-43d3e11c3cf4	7
309374	cloZAPine 200 MG Oral Tablet	PSN	d36c298b-7292-46e0-898f-43d3e11c3cf4	7
197536	cloZAPine 25 MG Oral Tablet	PSN	d36c298b-7292-46e0-898f-43d3e11c3cf4	7
429212	cloZAPine 50 MG Oral Tablet	PSN	d36c298b-7292-46e0-898f-43d3e11c3cf4	7
197535	clozapine 100 MG Oral Tablet	SCD	d36c298b-7292-46e0-898f-43d3e11c3cf4	7
309374	clozapine 200 MG Oral Tablet	SCD	d36c298b-7292-46e0-898f-43d3e11c3cf4	7
197536	clozapine 25 MG Oral Tablet	SCD	d36c298b-7292-46e0-898f-43d3e11c3cf4	7
429212	clozapine 50 MG Oral Tablet	SCD	d36c298b-7292-46e0-898f-43d3e11c3cf4	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-426-01	60687042601	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-426-01) / 1 TABLET in 1 BLISTER PACK (60687-426-11)	100 blister pack	2019-02-25	0000-00-00	No	No	Current
60687-426-11	60687042611	1 in 1 BLISTER PACK						Historical