Prescription drug · NDA
Natesto nasal gel (Testosterone) NDC 42667-5511
Testosterone 5.5 mg/.122g · Gel, Metered · Nasal · Acerus Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42667-5511-1 | 4266755110142667551101 | 1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATORMarketed from May 8, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Natesto nasal gelSuffix: nasal gel
- Generic name (nonproprietary)
- testosterone
- Active ingredients
- Testosterone — 5.5 mg/.122g
- Dosage form
- Gel, Metered
- Route
- Nasal
- Labeler
- Acerus Pharmaceuticals CorporationNDC labeler code 42667
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205488
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 42667-5511_1ed05dab-581e-42da-aafc-26c3a759e9acSPL ID 1ed05dab-581e-42da-aafc-26c3a759e9acSPL set ID dea6bed1-eaca-11e3-ac10-0800200c9a66RxCUI 1596782, 1596784UNII 3XMK78S47O
- Pharmacologic class
- Androgen
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442667551101followed by a unit qualifier and the quantityPackage 42667-5511-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hor…
Excerpt only. Read the full label for complete information.
About NDC 42667-5511
- What is NDC 42667-5511?
- 42667-5511 is the product NDC for Natesto nasal gel (testosterone), Testosterone 5.5 mg/.122g gel, metered, listed with the FDA by Acerus Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Natesto nasal gel (Testosterone).
- What is the active ingredient?
- Testosterone.
- Who is the labeler?
- Acerus Pharmaceuticals Corporation, NDC labeler code 42667. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Natesto nasal gel?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.