FDA.reportPublic FDA data

ANASTROZOLE

Product NDC
43063-383
11-digit product format
430630383
Labeler code
43063
Product ID
43063-383_2f271dc9-5d40-6feb-e063-6394a90a1450
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ANASTROZOLE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA079220
Marketing category
ANDA
Marketing start
2010-06-28
Substance
ANASTROZOLE
Active strength
1 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANASTROZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANASTROZOLE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2Z07MYW1AZ
Rxcui199224

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-383-06ANASTROZOLE6 in 1 BOTTLE, PLASTICTABLET616
43063-383-15ANASTROZOLE15 in 1 BOTTLE, PLASTICTABLET1516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-383-06EA - Each43063-3835ce22e7e-b63b-4318-a547-56eea7bb641212018-09-05
43063-383-15EA - Each43063-3836dc3e00f-f3d4-4d66-bb67-d5ee032d1d6012018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-383ANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20250302_5d4f90d4-e535-4681-a863-3d774a2064e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN5d4f90d4-e535-4681-a863-3d774a2064e616
199224anastrozole 1 MG Oral TabletSCD5d4f90d4-e535-4681-a863-3d774a2064e616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-383-06430630383066 TABLET in 1 BOTTLE, PLASTIC (43063-383-06) 6 tablet2018-08-230000-00-00NoNoCurrent
43063-383-154306303831515 TABLET in 1 BOTTLE, PLASTIC (43063-383-15) 15 tablet2018-08-200000-00-00NoNoCurrent