Anastrozole

Product NDC
0904-6195
11-digit product format
009046195
Labeler code
0904
Product ID
0904-6195_1bbc43c4-ae3a-4514-9d30-389da6c27da4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090568
Marketing category
ANDA
Marketing start
2010-06-15
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6195-46EA - Each0904-61950ace5e1e-b61d-45f9-8820-aa3ff8922be412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6195ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS]9Legacy NDC20240627_e46ed5b8-83c9-4adb-890f-0fc612371eea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6195-460090461954630 TABLET in 1 BOTTLE, PLASTIC (0904-6195-46) 30 tablet2010-06-150000-00-00NoNoCurrent