Anastrozole

Product NDC: 70934-488
11-digit product format: 709340488
Labeler code: 70934
Product ID: 70934-488_a838abc8-cd9d-b312-e053-2a95a90a3953
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anastrozole
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA090568
Marketing category: ANDA
Marketing start: 2020-01-08
Marketing end: 0000-00-00
Substance: ANASTROZOLE
Active strength: 1 mg/1
Pharmacologic classes: Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9495fd23-86bb-d8f7-ae78-6dfe2f4dae2d	Product name	3	20210204

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-488-10	2023-01-30	C162847	48780-1	f386c64a-1067-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-488-10	70934048810	10 TABLET in 1 BOTTLE, PLASTIC (70934-488-10)	10 tablet	2020-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anastrozole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-01-08	HUMAN PRESCRIPTION DRUG LABEL	1