Clozapine

Product NDC: 51079-288
11-digit product format: 510790288
Labeler code: 51079
Product ID: 51079-288_3a39cd16-5a3c-3d37-e063-6294a90abfc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clozapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA201824
Marketing category: ANDA
Marketing start: 2016-09-26
Substance: CLOZAPINE
Active strength: 100 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	100 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	J60AR2IKIC
Rxcui	476177

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
51079-288-01	Clozapine	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1		11
51079-288-04	Clozapine	40 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	40		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-288-01	EA - Each	51079-288	84fcd254-ab72-410e-8c9d-efbe01939017	1	2016-11-08
51079-288-04	EA - Each	51079-288	313c62b4-8e31-4155-86a6-544a3affe702	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-288	CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN INSTITUTIONAL INC.]	10	Current NDC, Legacy NDC, 2 package rows	20250516_976be6e3-a9db-49c6-9b02-1ab168cf17b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476177	cloZAPine 100 MG Disintegrating Oral Tablet	PSN	976be6e3-a9db-49c6-9b02-1ab168cf17b1	11
476177	clozapine 100 MG Disintegrating Oral Tablet	SCD	976be6e3-a9db-49c6-9b02-1ab168cf17b1	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-288-01	51079028801	1 in 1 BLISTER PACK						Historical
51079-288-04	51079028804	40 BLISTER PACK in 1 CARTON (51079-288-04) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-288-01)	40 blister pack	2016-09-26	0000-00-00	No	No	Current