What is NDC 0591-3217?

0591-3217 is the product NDC for Testosterone, Testosterone 10 mg/g gel, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Testosterone?

42 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Testosterone NDC 0591-3217 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-3217Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-3217Add 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
0591-3217-30	0059132173000591321730	30 PACKET in 1 CARTON (0591-3217-30) / 5 g in 1 PACKET (0591-3217-26)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.NDC labeler code 0591
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 0591-3217_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

N400591321730 followed by a unit qualifier and the quantity

Package 00591-3217-30. 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)

About NDC 0591-3217

What is NDC 0591-3217?: 0591-3217 is the product NDC for Testosterone, Testosterone 10 mg/g gel, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Testosterone.
What is the active ingredient?: Testosterone.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Testosterone?: 42 other product NDCs are listed under this name. See all Testosterone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Testosterone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Testosterone	Testosterone 30 mg/1.5mL	SolutionTopical	Encube Ethicals, Inc.	21922-109	21922-0109-16
Testosterone	Testosterone 25 mg/2.5g	GelTransdermal	Prasco Laboratories	66993-954	66993-0954-30
Testosterone	Testosterone 16.2 mg/g	GelTransdermal	Prasco Laboratories	66993-951	66993-0951-88
Testosterone	Testosterone 16.2 mg/g	GelTransdermal	Prasco Laboratories	66993-952	66993-0952-30
Testosterone	Testosterone 12.5 mg/1.25g	GelTransdermal	Prasco Laboratories	66993-953	66993-0953-44
Testosterone	Testosterone 50 mg/5g	GelTransdermal	Prasco Laboratories	66993-955	66993-0955-30
Testosterone	Testosterone 30 [hp_X]/1	TabletOral	Zoe Processing	44117-0003	44117-0003-01
Testosterone	Testosterone 16.2 mg/g	GelTransdermal	Encube Ethicals, Inc.	21922-030	21922-0030-2021922-0030-52
Testosterone	Testosterone 20.25 mg/1.25g	Gel, MeteredTransdermal	Northstar Rx LLC	72603-265	72603-0265-01
Testosterone	Testosterone 25 mg/2.5g	GelTransdermal	Strides Pharma Science Limited	64380-151	64380-0151-02

All 43 Testosterone NDCs

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.	0591-3216