Temozolomide

Product NDC: 0781-2696
11-digit product format: 007812696
Labeler code: 0781
Product ID: 0781-2696_11eaca7f-fe49-4e46-9af8-949cca418fbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc.
Application: NDA021029
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-08-12
Marketing end: 0000-00-00
Substance: TEMOZOLOMIDE
Active strength: 250 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-2696-75	2020-02-02	C162847	48780-1	9d75b9cf-f122-f424-e053-dadaa90a57ce	5d529b2d-d182-4d3d-a65d-613af39e254f
0781-2696-75	2020-01-31	C162847	48780-1	9d75b9cf-f122-f424-e053-dadaa90a57ce	5d529b2d-d182-4d3d-a65d-613af39e254f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2696-75	EA - Each	0781-2696	e228cdb4-5b1f-4cfb-95df-05519eb0bb81	1	2013-11-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2696-75	00781269675	1 BOTTLE, GLASS in 1 CARTON (0781-2696-75) > 5 CAPSULE in 1 BOTTLE, GLASS	2013-08-12	0000-00-00	No	No	Current