Prescription drug · NDA AUTHORIZED GENERIC
Testosterone NDC 0832-1121
Testosterone 12.5 mg/1 · Gel, Metered · Topical · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-1121-42 | 00832112142 | 2 BOTTLE, PUMP in 1 CARTON (0832-1121-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40)Marketed from Jun 16, 2014 |
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)
- Testosterone
- Generic name (nonproprietary)
- testosterone
- Active ingredients
- Testosterone — 12.5 mg/1
- Dosage form
- Gel, Metered
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 204399
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 0832-1121_39853cd7-bfd1-848f-e063-6294a90a49e4SPL ID 39853cd7-bfd1-848f-e063-6294a90a49e4SPL set ID a887020f-b41f-49fe-8379-f01147b2a796RxCUI 1596780, 1597129UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400832112142followed by a unit qualifier and the quantityPackage 00832-1121-42. 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)
Testosterone gel is indicated for 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 levels 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 pituitary-hypotha…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204399
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vogelxotestosterone | Testosterone 50 mg/5g | GelTopical | Upsher-Smith Laboratories, LLC | 0245-0871 |
| Vogelxotestosterone | Testosterone 12.5 mg/1 | Gel, MeteredTopical | Upsher-Smith Laboratories, LLC | 0245-0872 |
| Testosterone | Testosterone 50 mg/5g | GelTopical | Upsher-Smith Laboratories, LLC | 0832-1120 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.