Testosterone NDC 64380-151

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-151Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0151Add 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
64380-151-02	64380015102	30 DOSE PACK in 1 CARTON (64380-151-02) / 2.5 g in 1 DOSE PACK (64380-151-01)Marketed from Jun 27, 2022

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 — 25 mg/2.5g
Dosage form: Gel
Route: Transdermal
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076744
Marketing start: Jun 27, 2022
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 64380-151_6d50f17e-4607-458a-882b-620daa3b58a9SPL ID 6d50f17e-4607-458a-882b-620daa3b58a9SPL set ID ee54c393-bcfe-4a52-b7b3-1da8750f35d9RxCUI 1597123, 1597129UNII 3XMK78S47OUPC 0364380151012, 0364380152019
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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N464380015102 followed by a unit qualifier and the quantity

Package 64380-0151-02. 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 Aug 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Testosterone Gel 1% 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 (LHRH) d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076744

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

FDA NDC Directory listings under ANDA 076744
Product	Strength	Form · route	Labeler	Product NDC
Testosterone	Testosterone 50 mg/5g	GelTransdermal	Strides Pharma Science Limited	64380-152