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NDC 62135-0475-60 Danazol 50 mg/1 Details
Danazol 50 mg/1
Danazol is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Chartwell RX, LLC.. The primary component is DANAZOL.
MedlinePlus Drug Summary
Danazol is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding)..Danazol is also used to treat fibrocystic breast disease (swollen, tender breasts with noncancerous lumps) when other treatments are not successful. Danazol is also used to prevent attacks in people with hereditary angioedema (inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines). Danazol is in a class of medications called androgenic hormones. It works to treat endometriosis by shrinking the displaced tissue of the uterus. It works to treat fibrocystic breast disease by blocking the release of hormones that cause the breast pain and lumps. It works to treat hereditary angioedema by increasing the amount of a natural substance in the body.
Related Packages: 62135-0475-60Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Danazol
Product Information
| NDC | 62135-0475 |
|---|---|
| Product ID | 62135-475_f6008bf5-e5ff-8a0c-e053-2995a90ae19d |
| Associated GPIs | |
| GCN Sequence Number | 006602 |
| GCN Sequence Number Description | danazol CAPSULE 50 MG ORAL |
| HIC3 | P1F |
| HIC3 Description | PITUITARY SUPPRESSIVE AGENTS |
| GCN | 26062 |
| HICL Sequence Number | 002833 |
| HICL Sequence Number Description | DANAZOL |
| Brand/Generic | Generic |
| Proprietary Name | Danazol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Danazol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | DANAZOL |
| Labeler Name | Chartwell RX, LLC. |
| Pharmaceutical Class | Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078214 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62135-0475-60 (62135047560)
| NDC Package Code | 62135-475-60 |
|---|---|
| Billing NDC | 62135047560 |
| Package | 60 CAPSULE in 1 BOTTLE (62135-475-60) |
| Marketing Start Date | 2023-02-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |