CLOZAPINE

Product NDC
57664-345
11-digit product format
576640345
Labeler code
57664
Product ID
57664-345_5dab493f-f2b8-4841-9332-1d9d97451460
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOZAPINE
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075713
Marketing category
ANDA
Marketing start
2002-11-15
Marketing end
0000-00-00
Substance
CLOZAPINE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-345-13EA - Each57664-3459371aa67-2ed4-49ee-a89b-5ebf534f872412012-07-24
57664-345-88EA - Each57664-345b60c599e-85db-4b77-8927-5efe245eca2812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-345-1357664034513500 TABLET in 1 BOTTLE (57664-345-13) 500 tablet2002-11-150000-00-00NoNoCurrent
57664-345-8857664034588100 TABLET in 1 BOTTLE (57664-345-88) 100 tablet2002-11-150000-00-00NoNoCurrent