testosterone NDC 45802-281

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-281Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0281Add 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
45802-281-39	45802028139	30 PACKET in 1 CARTON (45802-281-39) / 1.25 g in 1 PACKET (45802-281-03)Marketed from Jun 27, 2019

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 — 20.25 mg/1.25g
Dosage form: Gel
Route: Topical
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205781
Marketing start: Jun 27, 2019
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 45802-281_a7c10e20-f92f-4b14-a281-8118abfd4809SPL ID a7c10e20-f92f-4b14-a281-8118abfd4809SPL set ID 54fcdcb9-fb0e-4164-9e51-f2a5feae3217RxCUI 1597076, 1597120, 1597126UNII 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

N445802028139 followed by a unit qualifier and the quantity

Package 45802-0281-39. 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 Aug 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Testosterone Gel, 1.62% 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 hormone …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205781

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

FDA NDC Directory listings under ANDA 205781
Product	Strength	Form · route	Labeler	Product NDC
testosterone	Testosterone 40.5 mg/2.5g	GelTopical	Northstar Rx LLC	16714-969
testosterone	Testosterone 20.25 mg/1.25g	GelTopical	Northstar Rx LLC	16714-968
testosterone	Testosterone 40.5 mg/2.5g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-366