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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2Z07MYW1AZ |
| Rxcui | 199224 |
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 [ACCORD HEALTHCARE INC.] | 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 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] | 5 | |
| POLYETHYLENE GLYCOL 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ANASTROZOLE TABLET [ACCORD HEALTHCARE INC.] | 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 | |
| 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 [DISPENSING SOLUTIONS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ANASTROZOLE TABLET [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ANASTROZOLE TABLET [PROFICIENT RX LP] | 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 [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ANASTROZOLE TABLET [PROFICIENT RX LP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ANASTROZOLE TABLET [PROFICIENT RX LP] | 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 [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ANASTROZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ANASTROZOLE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ANASTROZOLE TABLET [PROFICIENT RX LP] | 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 |
|---|
| 16729-035-10 | 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 |