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NDC 63481-0183-16 FORTESTA 10 mg/.5g Details
FORTESTA 10 mg/.5g
FORTESTA is a TOPICAL GEL, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Endo Pharmaceuticals Inc.. The primary component is TESTOSTERONE.
MedlinePlus Drug Summary
Testosterone topical is used to treat the symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain tests to check your testosterone levels to see if they are low before you begin to use testosterone topical. Testosterone should not be used to treat the symptoms of low testosterone in men who have low testosterone due to aging ('age related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone topical works by replacing the testosterone that is normally produced by the body.
Related Packages: 63481-0183-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Testosterone Topical
Product Information
| NDC | 63481-0183 |
|---|---|
| Product ID | 63481-183_0892bc7c-3157-43dd-a8f3-4758b23bf571 |
| Associated GPIs | 23100030004070 |
| GCN Sequence Number | 062542 |
| GCN Sequence Number Description | testosterone GEL MD PMP 10 MG (2%) TRANSDERM |
| HIC3 | F1A |
| HIC3 Description | ANDROGENIC AGENTS |
| GCN | 98317 |
| HICL Sequence Number | 001403 |
| HICL Sequence Number Description | TESTOSTERONE |
| Brand/Generic | Brand |
| Proprietary Name | FORTESTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | testosterone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL, METERED |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/.5g |
| Substance Name | TESTOSTERONE |
| Labeler Name | Endo Pharmaceuticals Inc. |
| Pharmaceutical Class | Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA021463 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63481-0183-16 (63481018316)
| NDC Package Code | 63481-183-16 |
|---|---|
| Billing NDC | 63481018316 |
| Package | 1 CANISTER in 1 CARTON (63481-183-16) / 60 g in 1 CANISTER |
| Marketing Start Date | 2010-12-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |