NDC codes

FDA NDC Directory
Product NDC (as listed)69087-198Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69087-0198Add 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 NDC11-digit (billing)PackageCopy
69087-198-126908701981212 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 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 — 198 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
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 69087-198_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

N469087019812 followed by a unit qualifier and the quantity

Package 69087-0198-12. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 206089

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

FDA NDC Directory listings under NDA 206089
ProductStrengthForm · routeLabelerProduct NDC
Jatenzotestosterone undecanoateTestosterone undecanoate 158 mg/1Capsule, Liquid filledOralTOLMAR Inc.69087-158
Jatenzotestosterone undecanoateTestosterone undecanoate 237 mg/1Capsule, Liquid filledOralTOLMAR Inc.69087-237

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Jatenzo (testosterone undecanoate) NDC 69087-198 | Med-Code