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NDC 42667-5511-01 Natesto 5.5 mg/.122g Details
Natesto 5.5 mg/.122g
Natesto is a NASAL GEL, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acerus Pharmaceuticals Corporation. The primary component is TESTOSTERONE.
MedlinePlus Drug Summary
Testosterone nasal gel is used to treat symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone nasal gel 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 use testosterone. 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 works by replacing testosterone that is normally produced by the body.
Related Packages: 42667-5511-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Testosterone Nasal Gel
Product Information
| NDC | 42667-5511 |
|---|---|
| Product ID | 42667-5511_f032bccc-33cf-4e7d-e053-2995a90ac5ea |
| Associated GPIs | 23100030004080 |
| GCN Sequence Number | 073643 |
| GCN Sequence Number Description | testosterone GEL MD PMP 5.5/0.122 NASAL |
| HIC3 | F1A |
| HIC3 Description | ANDROGENIC AGENTS |
| GCN | 38079 |
| HICL Sequence Number | 001403 |
| HICL Sequence Number Description | TESTOSTERONE |
| Brand/Generic | Brand |
| Proprietary Name | Natesto |
| Proprietary Name Suffix | nasal gel |
| Non-Proprietary Name | testosterone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL, METERED |
| Route | NASAL |
| Active Ingredient Strength | 5.5 |
| Active Ingredient Units | mg/.122g |
| Substance Name | TESTOSTERONE |
| Labeler Name | Acerus Pharmaceuticals Corporation |
| Pharmaceutical Class | Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA205488 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42667-5511-01 (42667551101)
| NDC Package Code | 42667-5511-1 |
|---|---|
| Billing NDC | 42667551101 |
| Package | 1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR |
| Marketing Start Date | 2020-05-08 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 39.5158 |
| Pricing Unit | GM |
| Effective Date | 2022-06-01 |
| NDC Description | NATESTO NASAL 5.5 MG/0.122 GM |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | B |
| As of Date | 2022-11-23 |