Olanzapine

Product NDC
69543-382
11-digit product format
695430382
Labeler code
69543
Product ID
69543-382_e78e66e4-82ab-47a9-8633-d304cb6bac1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals, LLC
Application
ANDA204319
Marketing category
ANDA
Marketing start
2018-01-19
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
8 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-382-30EA - Each69543-3824a07221a-b12c-4aae-a7bb-68c0fda907d512018-02-20
69543-382-90EA - Each69543-382b83521e1-c0a6-4d69-bdd9-475eb93c599512018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-382-306954303823030 TABLET in 1 BOTTLE (69543-382-30) 30 tablet2018-01-190000-00-00NoNoCurrent
69543-382-906954303829090 TABLET in 1 BOTTLE (69543-382-90) 90 tablet2018-01-190000-00-00NoNoCurrent