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NDC 69087-0198-12 Jatenzo 198 mg/1 Details
Jatenzo 198 mg/1
Jatenzo is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TOLMAR Inc.. The primary component is TESTOSTERONE UNDECANOATE.
MedlinePlus Drug Summary
Testosterone is used to treat symptoms of low testosterone in 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 lab tests to check your testosterone levels to see if they are low before you begin to take testosterone. Testosterone should not be used treat the symptoms of low testosterone in men who have low testosterone due to aging ('age-related hypogonadism'). 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 works by replacing testosterone that is normally produced by the body.
Related Packages: 69087-0198-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Testosterone
Product Information
| NDC | 69087-0198 |
|---|---|
| Product ID | 69087-198_9d993a99-6347-4121-a2b9-51e90565161f |
| Associated GPIs | 23100030800135 |
| GCN Sequence Number | 079620 |
| GCN Sequence Number Description | testosterone undecanoate CAPSULE 198 MG ORAL |
| HIC3 | F1A |
| HIC3 Description | ANDROGENIC AGENTS |
| GCN | 46153 |
| HICL Sequence Number | 007304 |
| HICL Sequence Number Description | TESTOSTERONE UNDECANOATE |
| Brand/Generic | Brand |
| Proprietary Name | Jatenzo |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | testosterone undecanoate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 198 |
| Active Ingredient Units | mg/1 |
| Substance Name | TESTOSTERONE UNDECANOATE |
| Labeler Name | TOLMAR Inc. |
| Pharmaceutical Class | Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA206089 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69087-0198-12 (69087019812)
| NDC Package Code | 69087-198-12 |
|---|---|
| Billing NDC | 69087019812 |
| Package | 12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2019-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |