Anastrozole

Product NDC: 68071-1682
11-digit product format: 680711682
Labeler code: 68071
Product ID: 68071-1682_2a31d4fb-10fb-a0b6-e063-6294a90af1d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anastrozole
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ANASTROZOLE	1 mg/1

Field, Values table
Field	Values
Unii	2Z07MYW1AZ
Rxcui	199224

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1682-3	2024-07-15	C162847	48780-1	ba0f9c33-3a53-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use anastrozole tablets safely and effectively. See full prescribing information for anastrozole tablets. Anastrozole tablet for oral use. Initial U.S. Approval: 1995
68071-1682-3	2023-01-30	C162847	48780-1	ba0f9c33-3a53-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use anastrozole tablets safely and effectively. See full prescribing information for anastrozole tablets. Anastrozole tablet for oral use. Initial U.S. Approval: 1995
68071-1682-3	2021-02-11	C162847	48780-1	ba0f9c33-3a53-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use anastrozole tablets safely and effectively. See full prescribing information for anastrozole tablets. Anastrozole tablet for oral use. Initial U.S. Approval: 1995
68071-1682-3	2021-01-29	C162847	48780-1	ba0f9c33-3a53-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use anastrozole tablets safely and effectively. See full prescribing information for anastrozole tablets. Anastrozole tablet for oral use. Initial U.S. Approval: 1995

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1682-3	Anastrozole	30 in 1 BOTTLE	TABLET	30		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1682	ANASTROZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241228_5a2d5052-95ce-d103-e053-2991aa0aa4be.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199224	anastrozole 1 MG Oral Tablet	PSN	5a2d5052-95ce-d103-e053-2991aa0aa4be	5
199224	anastrozole 1 MG Oral Tablet	SCD	5a2d5052-95ce-d103-e053-2991aa0aa4be	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1682-3	68071168203	30 TABLET in 1 BOTTLE (68071-1682-3)	30 tablet	2017-09-27	0000-00-00	No	No	Current