NDC codes

FDA NDC Directory
Product NDC (as listed)42667-5511Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42667-5511Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
42667-5511-142667551101426675511011 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

N442667551101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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