Testosterone NDC 0591-3216

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-3216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-3216Add 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
0591-3216-30	00591321630	30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17)Marketed from Dec 4, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/g
Dosage form: Gel
Route: Topical
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076737
Marketing start: Dec 4, 2015
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 0591-3216_38f554a5-ee64-4429-96c5-52b02c7763c1SPL ID 38f554a5-ee64-4429-96c5-52b02c7763c1SPL set ID 5834d34f-839d-412c-b74c-da1dad2cfa88RxCUI 1596780, 1597123, 1597129UNII 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

N400591321630 followed by a unit qualifier and the quantity

Package 00591-3216-30. 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 Sep 30, 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 076737

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

FDA NDC Directory listings under ANDA 076737
Product	Strength	Form · route	Labeler	Product NDC
Testosterone	Testosterone 10 mg/g	GelTopical	Actavis Pharma, Inc.	0591-2921
Testosterone	Testosterone 10 mg/g	GelTopical	Actavis Pharma, Inc.	0591-3217