Testosterone Gel, 1% NDC 21922-019

NDC codes

FDA NDC Directory

Product NDC (as listed)21922-019Labeler and product segments. Claims need a package NDC.

Product NDC at billing width21922-0019Add 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
21922-019-02	21922001902	30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKETMarketed from Jan 10, 2021
21922-019-47	21922001947	2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINERMarketed from Feb 14, 2024
21922-019-52	21922001952	30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKETMarketed from Aug 12, 2024

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 Gel, 1%
Generic name (nonproprietary): testosterone gel, 1%
Active ingredients: Testosterone — 10 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 212984
Marketing start: Jan 10, 2021
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 21922-019_afa51eef-714f-4b19-8c35-debee6cb00c4SPL ID afa51eef-714f-4b19-8c35-debee6cb00c4SPL set ID 7d655d6d-01da-488c-bd4e-c7fbe0ace38cRxCUI 1596780, 1597123, 1597129UNII 3XMK78S47OUPC 0321922019025
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

N421922001902 followed by a unit qualifier and the quantity

Package 21922-0019-02. 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 Oct 8, 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) …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212984

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

FDA NDC Directory listings under ANDA 212984
Product	Strength	Form · route	Labeler	Product NDC
Testosterone Gel, 1%	Testosterone 10 mg/g	GelTransdermal	Bryant Ranch Prepack	72162-1274