What is NDC 0115-1408?

0115-1408 is the product NDC for MethylTESTOSTERone, Methyltestosterone 10 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

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 MethylTESTOSTERone?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

MethylTESTOSTERone NDC 0115-1408 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1408Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1408Add 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 NDC	11-digit (billing)	Package
0115-1408-01	00115140801	100 CAPSULE in 1 BOTTLE (0115-1408-01)Marketed from Sep 21, 2015
0115-1408-03	00115140803	1000 CAPSULE in 1 BOTTLE (0115-1408-03)Marketed from Sep 21, 2015
0115-1408-08	00115140808	30 CAPSULE in 1 BOTTLE (0115-1408-08)Marketed from Sep 21, 2015

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): MethylTESTOSTERone
Generic name (nonproprietary): methyltestosterone
Active ingredients: Methyltestosterone — 10 mg/1
Dosage form: Capsule
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 204851
Marketing start: Sep 21, 2015
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 0115-1408_12d97eee-36cf-470e-819a-02ec2218fb94SPL ID 12d97eee-36cf-470e-819a-02ec2218fb94SPL set ID 9bed4886-fcd0-4056-be8d-5bb4d15081ceRxCUI 197975UNII V9EFU16ZIFUPC 0301151408012
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

N400115140801 followed by a unit qualifier and the quantity

Package 00115-1408-01. 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 May 31, 2025.

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 (congenital or acquired) — testicular failure due to cryptorchidism, bilateral torsions, 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-1408

What is NDC 0115-1408?: 0115-1408 is the product NDC for MethylTESTOSTERone, Methyltestosterone 10 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: 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 MethylTESTOSTERone?: 1 other product NDC are listed under this name. See all MethylTESTOSTERone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other MethylTESTOSTERone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methyltestosterone	Methyltestosterone 10 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	70954-255	70954-0255-10