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NDC 63629-7819-04 Letrozole 2.5 mg/1 Details
Letrozole 2.5 mg/1
Letrozole is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is LETROZOLE.
MedlinePlus Drug Summary
Letrozole is used treat early breast cancer in women who have experienced menopause (change of life; end of monthly menstrual periods) and who have had other treatments, such as radiation or surgery to remove the tumor. It is also used to treat early breast cancer in women who have experienced menopause and who have already been treated with a medication called tamoxifen (Nolvadex) for 5 years. Letrozole is also used in women who have experienced menopause as a first treatment of breast cancer that has spread within the breast or to other areas of the body or in women whose breast cancer has worsened while they were taking tamoxifen. Letrozole is in a class of medications called nonsteroidal aromatase inhibitors. It works by decreasing the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.
Related Packages: 63629-7819-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Letrozole
Product Information
| NDC | 63629-7819 |
|---|---|
| Product ID | 63629-7819_5643d810-e5a0-4774-8907-71281122346b |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Letrozole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | letrozole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 2.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LETROZOLE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090934 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-7819-04 (63629781904)
| NDC Package Code | 63629-7819-4 |
|---|---|
| Billing NDC | 63629781904 |
| Package | 40 TABLET, FILM COATED in 1 BOTTLE (63629-7819-4) |
| Marketing Start Date | 2020-11-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |