Prescription drug · ANDA
Methyltestosterone NDC 70954-255
Methyltestosterone 10 mg/1 · Capsule · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-255-10 | 70954025510 | 100 CAPSULE in 1 BOTTLE (70954-255-10)Marketed from Feb 18, 2022 |
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)
- Methyltestosterone
- Generic name (nonproprietary)
- methyltestosterone
- Active ingredients
- Methyltestosterone — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215270
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 70954-255_987b3eb2-8e19-4ad6-bfdd-670b511d8dd6SPL ID 987b3eb2-8e19-4ad6-bfdd-670b511d8dd6SPL set ID c09c4cde-9f6c-4c4f-9d96-18beb5377564RxCUI 197975UNII V9EFU16ZIFUPC 0370954255109
- 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
N470954025510followed by a unit qualifier and the quantityPackage 70954-0255-10. 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 & 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 to…
Excerpt only. Read the full label for complete information.
About NDC 70954-255
- What is NDC 70954-255?
- 70954-255 is the product NDC for Methyltestosterone, Methyltestosterone 10 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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.
Related NDCs: other Methyltestosterone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| MethylTESTOSTERone | Methyltestosterone 10 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-1408 | 00115-1408-0100115-1408-0300115-1408-08 |