NDC codes

FDA NDC Directory
Product NDC (as listed)74676-0112Labeler and product segments. Claims need a package NDC.
Product NDC at billing width74676-0112Add 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
74676-0112-274676011202120 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
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

N474676011202 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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