Prescription drug · UNAPPROVED DRUG OTHER
Testone CIK NDC 76420-650
testosterone cypionate, alcohol · Kit · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-650-01 | 76420065001 | 1 KIT in 1 CARTON (76420-650-01) * 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS * 1.4 mL in 1 POUCHMarketed from May 23, 2016 |
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)
- Testone CIK
- Generic name (nonproprietary)
- testosterone cypionate, alcohol
- Dosage form
- Kit
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 76420-650_23e81cde-1d04-4e23-ba5c-97f6e1e08495SPL ID 23e81cde-1d04-4e23-ba5c-97f6e1e08495SPL set ID edcd5209-70db-4727-991e-3fdd185d9211RxCUI 797544, 835840, 2047882
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N476420065001followed by a unit qualifier and the quantityPackage 76420-0650-01. 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 Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Excerpt only. Read the full label for complete information.