Olanzapine

Product NDC: 69543-385
11-digit product format: 695430385
Labeler code: 69543
Product ID: 69543-385_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: 20 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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42e9462d-db65-453b-8069-8fb2df9182e8	Product name	1	20211216
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-385-30	EA - Each	69543-385	80fd6cb9-54dd-4bb7-8ab0-a4d613841e68	1	2018-02-20
69543-385-90	EA - Each	69543-385	0caff279-789e-42a0-bd14-94f86772ca95	1	2018-02-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283639	OLANZapine 20 MG Oral Tablet	PSN	1ece23ae-2d4b-d6d7-e063-6394a90ac3b1	1
283639	olanzapine 20 MG Oral Tablet	SCD	1ece23ae-2d4b-d6d7-e063-6394a90ac3b1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69543-385-30	69543038530	30 TABLET in 1 BOTTLE (69543-385-30)	30 tablet	2018-01-19	0000-00-00	No	No	Current
69543-385-90	69543038590	90 TABLET in 1 BOTTLE (69543-385-90)	90 tablet	2018-01-19	0000-00-00	No	No	Current