Prescription drug · NDA
Jatenzo (testosterone undecanoate) NDC 69087-158
Testosterone undecanoate 158 mg/1 · Capsule, Liquid filled · Oral · TOLMAR Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69087-158-12 | 69087015812 | 12 BOTTLE, PLASTIC in 1 BOX (69087-158-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Aug 1, 2019 |
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)
- Jatenzo
- Generic name (nonproprietary)
- testosterone undecanoate
- Active ingredients
- Testosterone undecanoate — 158 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- TOLMAR Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206089
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 69087-158_9db3c914-8c33-4b65-86d3-5dc5c775b00bSPL ID 9db3c914-8c33-4b65-86d3-5dc5c775b00bSPL set ID ed7b5d41-7475-4c10-99b9-b62b3434ae60RxCUI 2121766, 2121768, 2121770, 2121776, 2201640, 2201642UNII H16A5VCT9C
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469087015812followed by a unit qualifier and the quantityPackage 69087-0158-12. 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 .
Indications (excerpt from the label)
JATENZO (testosterone undecanoate) is an androgen indicated for testosterone 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 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 luteiniz…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 206089
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Jatenzotestosterone undecanoate | Testosterone undecanoate 198 mg/1 | Capsule, Liquid filledOral | TOLMAR Inc. | 69087-198 |
| Jatenzotestosterone undecanoate | Testosterone undecanoate 237 mg/1 | Capsule, Liquid filledOral | TOLMAR Inc. | 69087-237 |