Prescription drug · NDA
Tlando (testosterone undecanoate) NDC 74676-0112
Testosterone undecanoate 112.5 mg/1 · Capsule, Liquid filled · Oral · Verity Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 74676-0112-2 | 74676011202 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (74676-0112-2)Marketed from Apr 15, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tlando
- Generic name (nonproprietary)
- testosterone undecanoate
- Active ingredients
- Testosterone undecanoate — 112.5 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Verity Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208088
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 74676-0112_2bcfa6a9-635f-6bc9-ec72-839cca27541eSPL ID 2bcfa6a9-635f-6bc9-ec72-839cca27541eSPL set ID 4b0b92e9-6d3c-a0e5-e1c7-342999f72580RxCUI 2599054, 2599060UNII H16A5VCT9CUPC 0374676011227
- 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
N474676011202followed by a unit qualifier and the quantityPackage 74676-0112-02. 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 .
Indications (excerpt from the label)
TLANDO is 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'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 [see Dosage and Administration ( 2.2 )]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or lutein…
Excerpt only. Read the full label for complete information.