Olanzapine

Product NDC
69543-384
11-digit product format
695430384
Labeler code
69543
Product ID
69543-384_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
15 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
69543-384-30EA - Each69543-384a3c9996b-2434-44df-bd5d-763a40bc066b12018-02-20
69543-384-90EA - Each69543-384066e6a3c-c729-4b5e-a05e-b33ee40ace0012018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-384-306954303843030 TABLET in 1 BOTTLE (69543-384-30) 30 tablet2018-01-190000-00-00NoNoCurrent
69543-384-906954303849090 TABLET in 1 BOTTLE (69543-384-90) 90 tablet2018-01-190000-00-00NoNoCurrent