Home NDC 16729-035-15 Anastrozole
Product NDC 16729-035
Requested package NDC 16729-035-15
11-digit product format 167290035
Labeler code 16729
Product ID 16729-035_4a900d2c-12d3-6bfa-e063-6294a90af009
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anastrozole
Dosage form TABLET
Route ORAL
Labeler Accord Healthcare Inc.
Application ANDA090568
Marketing category ANDA
Marketing start 2010-06-22
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 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 A090568-001 ANASTROZOLE ANASTROZOLE 1MG TABLET / ORAL AB 2010-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090568-001 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 A090568-001 ANASTROZOLE 1MG TABLET / ORAL AB 2010-06-28 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 A090568-001 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 · 11 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anastrozole ANASTROZOLE PD-Rx Pharmaceuticals, Inc. aabd8f88-2b52-4d43-8dc6-61605988c4dc 2026-07-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE Asclemed USA, Inc. b964f555-25d2-47ad-8942-f195f062445c 2026-02-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE Accord Healthcare Inc. 03586c40-eb32-45c5-beb7-6762a6b78790 2026-02-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (package): 16729-035-15 ndc (product): 16729-035 ndc11 (package): 16729003515 Anastrozole ANASTROZOLE NuCare Pharmaceuticals,Inc. e3b5fc92-9189-6944-e053-2a95a90a1c9f 2025-04-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ANASTROZOLE ANASTROZOLE Direct_Rx f37db328-bb81-9df9-e053-2a95a90a6f43 2025-01-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE NuCare Pharmaceuticals,Inc. 5a2d5052-95ce-d103-e053-2991aa0aa4be 2024-12-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE Bryant Ranch Prepack 19251d0b-279a-49f5-99b2-0e74d7cca479 2024-08-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE NuCare Pharmaceuticals,Inc. a0acddf1-a973-bf37-e053-2995a90a0bd5 2024-06-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE A-S Medication Solutions 03fb3108-1856-466d-bf88-0eac96139551 2024-06-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE NuCare Pharmaceuticals,Inc. ef6c9f7c-a1b0-3fee-e053-2995a90ab2c4 2024-04-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568 Anastrozole ANASTROZOLE Proficient Rx LP c7a36fd8-530e-4c63-97d5-0f80fab5880e 2023-05-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090568 application number: ANDA090568
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16729-035-10 Anastrozole 30 in 1 BOTTLE, PLASTIC TABLET 30 11 16729-035-15 Anastrozole 90 in 1 BOTTLE, PLASTIC TABLET 90 11 16729-035-16 Anastrozole 500 in 1 BOTTLE, PLASTIC TABLET 500 11 16729-035-17 Anastrozole 1000 in 1 BOTTLE, PLASTIC TABLET 1000 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 POLYETHYLENE GLYCOL 300 INACTIVE INGREDIENT 5655G9Y8AQ ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 POVIDONES INACTIVE INGREDIENT FZ989GH94E ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANASTROZOLE TABLET [BRYANT RANCH PREPACK] 1001 ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 POLYETHYLENE GLYCOL 300 INACTIVE INGREDIENT 5655G9Y8AQ ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 POVIDONE INACTIVE INGREDIENT FZ989GH94E ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANASTROZOLE TABLET [MAJOR PHARMACEUTICALS] 5 ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ANASTROZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC] 1 ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ANASTROZOLE TABLET [PROFICIENT RX LP] 1 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ANASTROZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC] 1 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ANASTROZOLE TABLET [PROFICIENT RX LP] 1 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ANASTROZOLE TABLET [PROFICIENT RX LP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ANASTROZOLE TABLET [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANASTROZOLE TABLET [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 300 INACTIVE INGREDIENT 5655G9Y8AQ ANASTROZOLE TABLET [PROFICIENT RX LP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ANASTROZOLE TABLET [PROFICIENT RX LP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ANASTROZOLE TABLET [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANASTROZOLE TABLET [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-035 ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] 10 Current NDC, Legacy NDC, 4 package rows 20250524_03586c40-eb32-45c5-beb7-6762a6b78790.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16729-035-15 16729003515 90 TABLET in 1 BOTTLE, PLASTIC (16729-035-15) 90 tablet 2011-02-24 0000-00-00 No No Current