Home NDC 72789-575 Anastrozole
Product NDC 72789-575
11-digit product format 727890575
Labeler code 72789
Product ID 72789-575_585069f8-4571-1711-e063-6394a90a9186
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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212434-001 ANASTROZOLE 1MG TABLET / ORAL AB 2020-07-24 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-575-15 72789057515 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-575-15) 2026-06-22 No No Current 72789-575-30 72789057530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-575-30) 2026-08-05 No No Current