Anastrozole

Product NDC: 67877-171
11-digit product format: 678770171
Labeler code: 67877
Product ID: 67877-171_4dcb2dbc-c4c1-43a4-950d-b24062e4d174
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anastrozole
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA079220
Marketing category: ANDA
Marketing start: 2010-06-28
Marketing end: 0000-00-00
Substance: ANASTROZOLE
Active strength: 1 mg/1
Pharmacologic classes: Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67877-171-10	2019-10-29	C162847	48780-1	960f7f55-c02f-8e05-e053-dbdaa90a074a	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use anastrozole tablets safely and effectively. See full prescribing information for anastrozole tablets. Initial U.S. Approval
67877-171-30	2019-10-29	C162847	48780-1	960f7f55-d328-8e05-e053-dbdaa90a074a	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use anastrozole tablets safely and effectively. See full prescribing information for anastrozole tablets. Initial U.S. Approval

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-171-30	Anastrozole	30 in 1 BOTTLE	TABLET	30		7
67877-171-10	Anastrozole	1000 in 1 BOTTLE	TABLET	1000		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-171-10	EA - Each	67877-171	36099f56-7c06-4493-8cec-88776e8d056c	1	2012-07-24
67877-171-30	EA - Each	67877-171	517e9b81-6c6c-4528-a0e9-db063056b170	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ANASTROZOLE	ACTIVE INGREDIENT	2Z07MYW1AZ	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
ANASTROZOLE	ACTIVE MOIETY	2Z07MYW1AZ	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7
ANASTROZOLE	ACTIVE INGREDIENT	2Z07MYW1AZ	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
ANASTROZOLE	ACTIVE MOIETY	2Z07MYW1AZ	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6
ANASTROZOLE	ACTIVE INGREDIENT	2Z07MYW1AZ	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ANASTROZOLE	ACTIVE MOIETY	2Z07MYW1AZ	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ANASTROZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ANASTROZOLE	ACTIVE INGREDIENT	2Z07MYW1AZ	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
ANASTROZOLE	ACTIVE MOIETY	2Z07MYW1AZ	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP]	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
67877-171	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	7	Legacy NDC, 1 package rows	20110323_4a23dc55-9877-4b43-ac2c-cd628c0f5038.zip
67877-171	ANASTROZOLE TABLET [ASCEND LABORATORIES, LLC]	6	Legacy NDC, 1 package rows	20110323_c7666def-a855-4ca3-a322-603a88a44101.zip

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	4a23dc55-9877-4b43-ac2c-cd628c0f5038	7
199224	anastrozole 1 MG Oral Tablet	SCD	4a23dc55-9877-4b43-ac2c-cd628c0f5038	7
199224	anastrozole 1 MG Oral Tablet	PSN	c7666def-a855-4ca3-a322-603a88a44101	6
199224	anastrozole 1 MG Oral Tablet	SCD	c7666def-a855-4ca3-a322-603a88a44101	6
199224	anastrozole 1 MG Oral Tablet	PSN	1448e72e-dc7f-4618-9b37-a82c59823839	2
199224	anastrozole 1 MG Oral Tablet	SCD	1448e72e-dc7f-4618-9b37-a82c59823839	2
199224	anastrozole 1 MG Oral Tablet	PSN	611e1f43-1442-4cbb-b7eb-b65de15c6c70	1
199224	anastrozole 1 MG Oral Tablet	SCD	611e1f43-1442-4cbb-b7eb-b65de15c6c70	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67877-171-10	67877017110	1000 in 1 BOTTLE	Historical
67877-171-30	67877017130	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anastrozole	Ascend Laboratories, LLC	2011-03-22	HUMAN PRESCRIPTION DRUG LABEL	6
Anastrozole	Ascend Laboratories, LLC	2011-03-21	HUMAN PRESCRIPTION DRUG LABEL	7
Anastrozole	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
Anastrozole	Physicians Total Care, Inc.	2010-07-22	HUMAN PRESCRIPTION DRUG LABEL	2

Anastrozole

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#