Olanzapine

Product NDC: 58118-3111
11-digit product format: 581183111
Labeler code: 58118
Product ID: 58118-3111_8d7f6b80-ed4c-63c8-e053-2a95a90a8760
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA090798
Marketing category: ANDA
Marketing start: 2012-04-23
Marketing end: 0000-00-00
Substance: OLANZAPINE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58118-3111-8	2021-01-29	C162847	48780-1	ba0f9c33-2782-a910-e053-dadaa90a0b85	97095119-28e7-4c9b-8727-ad5ea6010f7e

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-3111	OLANZAPINE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	3	Legacy NDC	20190713_97095119-28e7-4c9b-8727-ad5ea6010f7e.zip