Home NDC 72789-575-15 Anastrozole
Product NDC 72789-575
Requested package NDC 72789-575-15
11-digit product format 727890575
Labeler code 72789
Product ID 72789-575_54da506a-c173-eaa6-e063-6294a90a3e6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anastrozole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA212434
Marketing category ANDA
Marketing start 2026-06-22
Substance ANASTROZOLE
Active strength 1 mg/1
Pharmacologic classes Aromatase Inhibitor [EPC]; Aromatase Inhibitors [MoA]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212434-001 ANASTROZOLE ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212434-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A212434-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Anastrozole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANASTROZOLE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2Z07MYW1AZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 72789-575-15 72789057515 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-575-15) 2026-06-22 0 Current