Testosterone NDC 21922-030

NDC codes

FDA NDC Directory

Product NDC (as listed)21922-030Labeler and product segments. Claims need a package NDC.

Product NDC at billing width21922-0030Add 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
21922-030-20	21922003020	1 BOTTLE, PUMP in 1 CARTON (21922-030-20) / 88 g in 1 BOTTLE, PUMPMarketed from Jun 5, 2024
21922-030-52	21922003052	30 PACKET in 1 CARTON (21922-030-52) / 2.5 g in 1 PACKET (21922-030-55)Marketed from Jun 1, 2026

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 — 16.2 mg/g
Dosage form: Gel
Route: Transdermal
Labeler: Encube Ethicals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208620
Marketing start: Jun 5, 2024
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 21922-030_2606e20e-2be6-47ec-b599-ecd3238f4932SPL ID 2606e20e-2be6-47ec-b599-ecd3238f4932SPL set ID 44a04f66-fd2a-45c7-934e-8f14c023ce14RxCUI 1597076UNII 3XMK78S47OUPC 0321922030204, 0321922030525
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

N421922003020 followed by a unit qualifier and the quantity

Package 21922-0030-20. 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 5, 2026. 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 208620

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

FDA NDC Directory listings under ANDA 208620
Product	Strength	Form · route	Labeler	Product NDC
Testosterone	Testosterone 1.62 mg/g	Gel, MeteredTransdermal	Dr. Reddy's Laboratories, Inc.	43598-304