testosterone NDC 45802-610

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0610Add 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 NDC	11-digit (billing)	Package	Copy
45802-610-01	45802061001	1 BOTTLE, PUMP in 1 CARTON (45802-610-01) / 110 mL in 1 BOTTLE, PUMPMarketed from Jun 28, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204255
Marketing start: Jun 28, 2017
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 45802-610_49fac6b0-d016-4de8-a375-64de3e07aaa0SPL ID 49fac6b0-d016-4de8-a375-64de3e07aaa0SPL set ID c0c56607-e995-4bed-9c62-e33a722b38b5RxCUI 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

N445802061001 followed by a unit qualifier and the quantity

Package 45802-0610-01. 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 Jun 30, 2025. 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
Product	Strength	Form · route	Labeler	Product NDC
testosterone	Testosterone 30 mg/1.5mL	SolutionTopical	Bryant Ranch Prepack	72162-1421
testosterone	Testosterone 30 mg/1.5mL	SolutionTopical	Bryant Ranch Prepack	63629-9310