NDC codes

FDA NDC Directory
Product NDC (as listed)0115-7037Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00115-7037Add 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
0115-7037-0100115703701100 TABLET in 1 BOTTLE (0115-7037-01)Marketed from Oct 17, 1974

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Methitest
Generic name (nonproprietary)
methyltestosterone
Active ingredients
Methyltestosterone — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 080767
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 0115-7037_d5da1ec5-4a9e-4714-9240-039f802b2c1eSPL ID d5da1ec5-4a9e-4714-9240-039f802b2c1eSPL set ID 77bb4ef4-c10e-4acc-8225-651d003f4561RxCUI 197976, 541524UNII V9EFU16ZIFUPC 0301157037018
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

N400115703701 followed by a unit qualifier and the quantity

Package 00115-7037-01. 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)

INDICATIONS AND USAGE 1. Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) — Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-7037

What is NDC 0115-7037?
0115-7037 is the product NDC for Methitest (methyltestosterone), Methyltestosterone 10 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methitest (Methyltestosterone).
What is the active ingredient?
Methyltestosterone.
Who is the labeler?
Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methitest?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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