NDC codes

FDA NDC Directory
Product NDC (as listed)72162-1421Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-1421Add 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
72162-1421-2721621421021 BOTTLE, PUMP in 1 CARTON (72162-1421-2) / 110 mL in 1 BOTTLE, PUMPMarketed from Jan 11, 2024

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)
testosterone
Generic name (nonproprietary)
testosterone
Active ingredients
Testosterone — 30 mg/1.5mL
Dosage form
Solution
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204255
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 72162-1421_78ca5df2-0a66-41fe-9f28-4ba270cfce81SPL ID 78ca5df2-0a66-41fe-9f28-4ba270cfce81SPL set ID 5be74193-de73-436d-a9a1-35a857bc8e0cRxCUI 1599949UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472162142102 followed by a unit qualifier and the quantity

Package 72162-1421-02. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Testosterone Topical Solution is indicated for replacement therapy in 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 (FSH, LH) above the normal range. • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury fr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204255

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204255
ProductStrengthForm · routeLabelerProduct NDC
testosteroneTestosterone 30 mg/1.5mLSolutionTopicalPadagis Israel Pharmaceuticals Ltd45802-610
testosteroneTestosterone 30 mg/1.5mLSolutionTopicalBryant Ranch Prepack63629-9310

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