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 | 6908701581269087015812 | 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.NDC labeler code 69087
- 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_5bfbae09-d22e-4a86-a6a6-37fd926a3890SPL ID 5bfbae09-d22e-4a86-a6a6-37fd926a3890
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69087-158
- What is NDC 69087-158?
- 69087-158 is the product NDC for Jatenzo (testosterone undecanoate), Testosterone undecanoate 158 mg/1 capsule, liquid filled, listed with the FDA by TOLMAR Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jatenzo (Testosterone undecanoate).
- What is the active ingredient?
- Testosterone undecanoate.
- Who is the labeler?
- TOLMAR Inc., NDC labeler code 69087. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jatenzo?
- 2 other product NDCs are listed under this name. See all Jatenzo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jatenzo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jatenzotestosterone undecanoate | Testosterone undecanoate 198 mg/1 | Capsule, Liquid filledOral | TOLMAR Inc. | 69087-198 | 69087-0198-12 |
| Jatenzotestosterone undecanoate | Testosterone undecanoate 237 mg/1 | Capsule, Liquid filledOral | TOLMAR Inc. | 69087-237 | 69087-0237-1269087-0237-28 |
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 |