CLOZAPINE

Product NDC
57664-347
11-digit product format
576640347
Labeler code
57664
Product ID
57664-347_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
100 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
57664-347-13EA - Each57664-34732cae948-9a7a-4c8e-bfce-9a8c1237b81612012-07-24
57664-347-88EA - Each57664-347892d4a57-af36-489b-9eaa-a5bc4974da4c12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-347-1357664034713500 TABLET in 1 BOTTLE (57664-347-13) 500 tablet2002-11-150000-00-00NoNoCurrent
57664-347-8857664034788100 TABLET in 1 BOTTLE (57664-347-88) 100 tablet2002-11-150000-00-00NoNoCurrent