Anastrozole
These highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. Anastrozole tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
df55dc4c-9a53-4a37-a90f-c4e88d458b89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2020
Manufacturers
FDA
Natco Pharma Limited
DUNS: 650224736
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Anastrozole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63850-0010
Application NumberANDA079220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Anastrozole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2019
FDA Product Classification
INGREDIENTS (8)
ANASTROZOLEActive
Quantity: 1 mg in 1 1
Code: 2Z07MYW1AZ
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 3/22/2019
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.4) 12/2018