FDA.reportPublic FDA data

ARIMIDEX

Product NDC
0310-0201
11-digit product format
003100201
Labeler code
0310
Product ID
0310-0201_a11a1b6f-a483-457d-92c2-6140f6b2d83e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA020541
Marketing category
NDA
Marketing start
1996-01-16
Marketing end
2019-06-30
Substance
ANASTROZOLE
Active strength
1 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
No
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANASTROZOLE1 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9495fd23-86bb-d8f7-ae78-6dfe2f4dae2dProduct name320210204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0201-30EA - Each0310-020122a71aee-ef04-4dbc-95d4-542d39077ba712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN4fee8d4c-bb21-4773-b622-87f9a4ff333a2
151124Arimidex 1 MG Oral TabletPSN4fee8d4c-bb21-4773-b622-87f9a4ff333a2
151124anastrozole 1 MG Oral Tablet [Arimidex]SBD4fee8d4c-bb21-4773-b622-87f9a4ff333a2
199224anastrozole 1 MG Oral TabletSCD4fee8d4c-bb21-4773-b622-87f9a4ff333a2
151124Arimidex 1 MG Oral TabletSY4fee8d4c-bb21-4773-b622-87f9a4ff333a2