Prescription drug · NDA
Testim (testosterone) NDC 66887-001
Testosterone 50 mg/5g · Gel · Transdermal · Endo USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66887-001-05 | 66887000105 | 30 TUBE in 1 CARTON (66887-001-05) / 5 g in 1 TUBEMarketed from Oct 31, 2002 |
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)
- Testim
- Generic name (nonproprietary)
- testosterone
- Active ingredients
- Testosterone — 50 mg/5g
- Dosage form
- Gel
- Route
- Transdermal
- Labeler
- Endo USA, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021454
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 66887-001_366a5e88-4a23-46b0-94e5-e7f7deb7acbeSPL ID 366a5e88-4a23-46b0-94e5-e7f7deb7acbeSPL set ID 9f2aae1f-898d-4955-be31-678e0cf85395RxCUI 1597129, 1597132UNII 3XMK78S47O
- 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N466887000105followed by a unit qualifier and the quantityPackage 66887-0001-05. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
TESTIM 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 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. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituit…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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