Anastrozole

Product NDC: 16729-035
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 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090568-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090568-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090568-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090568-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090568-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090568-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090568-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090568-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090568-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090568-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090568-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090568-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090568-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090568-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090568-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090568-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090568-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090568-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090568-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090568-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090568-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090568-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090568-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090568-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090568-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090568-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090568-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090568-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090568-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090568-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090568-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090568-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090568-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090568-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090568-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090568-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090568-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090568-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090568-001	AB	1	`e64feba35796…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
03586c40-eb32-45c5-beb7-6762a6b78790	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9495fd23-86bb-d8f7-ae78-6dfe2f4dae2d	Product name	3	20210204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-035-10	EA - Each	16729-035	f3bee17f-5c8a-4f7f-9dd9-6daca91b6e62	1	2012-07-24
16729-035-15	EA - Each	16729-035	998f9f25-5ae0-40be-b774-9c3b2ee84f39	1	2013-02-13
16729-035-16	EA - Each	16729-035	1955c597-70f2-4c95-86b0-e14acf1ca10f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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 · 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 (product): 16729-035
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2Z07MYW1AZ	ANASTROZOLE	120511-73-1	ANASTROZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199224	anastrozole 1 MG Oral Tablet	PSN	19251d0b-279a-49f5-99b2-0e74d7cca479	1018
199224	anastrozole 1 MG Oral Tablet	SCD	19251d0b-279a-49f5-99b2-0e74d7cca479	1018
199224	anastrozole 1 MG Oral Tablet	PSN	03fb3108-1856-466d-bf88-0eac96139551	20
199224	anastrozole 1 MG Oral Tablet	SCD	03fb3108-1856-466d-bf88-0eac96139551	20
199224	anastrozole 1 MG Oral Tablet	PSN	aabd8f88-2b52-4d43-8dc6-61605988c4dc	17
199224	anastrozole 1 MG Oral Tablet	SCD	aabd8f88-2b52-4d43-8dc6-61605988c4dc	17
199224	anastrozole 1 MG Oral Tablet	PSN	03586c40-eb32-45c5-beb7-6762a6b78790	11
199224	anastrozole 1 MG Oral Tablet	SCD	03586c40-eb32-45c5-beb7-6762a6b78790	11
199224	anastrozole 1 MG Oral Tablet	PSN	c7a36fd8-530e-4c63-97d5-0f80fab5880e	7
199224	anastrozole 1 MG Oral Tablet	SCD	c7a36fd8-530e-4c63-97d5-0f80fab5880e	7
199224	anastrozole 1 MG Oral Tablet	PSN	e3b5fc92-9189-6944-e053-2a95a90a1c9f	5
199224	anastrozole 1 MG Oral Tablet	PSN	5a2d5052-95ce-d103-e053-2991aa0aa4be	5
199224	anastrozole 1 MG Oral Tablet	SCD	e3b5fc92-9189-6944-e053-2a95a90a1c9f	5
199224	anastrozole 1 MG Oral Tablet	SCD	5a2d5052-95ce-d103-e053-2991aa0aa4be	5
199224	anastrozole 1 MG Oral Tablet	PSN	a0acddf1-a973-bf37-e053-2995a90a0bd5	3
199224	anastrozole 1 MG Oral Tablet	PSN	b964f555-25d2-47ad-8942-f195f062445c	3
199224	anastrozole 1 MG Oral Tablet	SCD	b964f555-25d2-47ad-8942-f195f062445c	3
199224	anastrozole 1 MG Oral Tablet	SCD	a0acddf1-a973-bf37-e053-2995a90a0bd5	3
199224	anastrozole 1 MG Oral Tablet	PSN	ef6c9f7c-a1b0-3fee-e053-2995a90ab2c4	2
199224	anastrozole 1 MG Oral Tablet	PSN	f37db328-bb81-9df9-e053-2a95a90a6f43	2
199224	anastrozole 1 MG Oral Tablet	SCD	ef6c9f7c-a1b0-3fee-e053-2995a90ab2c4	2
199224	anastrozole 1 MG Oral Tablet	SCD	f37db328-bb81-9df9-e053-2a95a90a6f43	2
199224	anastrozole 1 MG Oral Tablet	PSN	d4f43676-0746-4765-9689-3f1e3075fa6a	1
199224	anastrozole 1 MG Oral Tablet	PSN	ddc99d79-fb94-4a91-9c39-9dcdb3dd5d5b	1
199224	anastrozole 1 MG Oral Tablet	PSN	7d792fea-6bf9-0994-e053-2a91aa0a20c1	1
199224	anastrozole 1 MG Oral Tablet	SCD	d4f43676-0746-4765-9689-3f1e3075fa6a	1
199224	anastrozole 1 MG Oral Tablet	SCD	ddc99d79-fb94-4a91-9c39-9dcdb3dd5d5b	1
199224	anastrozole 1 MG Oral Tablet	SCD	7d792fea-6bf9-0994-e053-2a91aa0a20c1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-035-10	16729003510	30 TABLET in 1 BOTTLE, PLASTIC (16729-035-10)	30 tablet	2010-06-22	0000-00-00	No	No	Current
16729-035-15	16729003515	90 TABLET in 1 BOTTLE, PLASTIC (16729-035-15)	90 tablet	2011-02-24	0000-00-00	No	No	Current
16729-035-16	16729003516	500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16)	500 tablet	2011-03-21	0000-00-00	No	No	Current
16729-035-17	16729003517	1000 in 1 BOTTLE, PLASTIC						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anastrozole	PD-Rx Pharmaceuticals, Inc.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	18
Anastrozole	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-02-14	HUMAN PRESCRIPTION DRUG LABEL	3
Anastrozole	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2026-02-11	HUMAN PRESCRIPTION DRUG LABEL	11
Anastrozole	REMEDYREPACK INC.	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	8
Anastrozole	NuCare Pharmaceuticals,Inc.	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	5
ANASTROZOLE	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Anastrozole	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	5
Anastrozole	Bryant Ranch Prepack	2024-08-22	HUMAN PRESCRIPTION DRUG LABEL	1018
Anastrozole	Major Pharmaceuticals	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL	9
Anastrozole	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
Anastrozole	A-S Medication Solutions	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	20
Anastrozole	NuCare Pharmaceuticals,Inc.	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	2
Anastrozole	REMEDYREPACK INC.	2023-11-29	HUMAN PRESCRIPTION DRUG LABEL	6
Anastrozole	Proficient Rx LP	2023-05-01	HUMAN PRESCRIPTION DRUG LABEL	7
Anastrozole	Preferred Pharmaceuticals, Inc.	2020-03-03	HUMAN PRESCRIPTION DRUG LABEL	5
Anastrozole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-01-08	HUMAN PRESCRIPTION DRUG LABEL	1
Anastrozole	medsource pharmaceuticals	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	1
Anastrozole	Northwind Pharmaceuticals, LLC	2014-11-10	HUMAN PRESCRIPTION DRUG LABEL	1
Anastrozole	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-10-23	HUMAN PRESCRIPTION DRUG LABEL	1
Anastrozole	Rebel Distributors Corp	2012-02-29	HUMAN PRESCRIPTION DRUG LABEL	1