Prescription drug · ANDA
Testosterone NDC 24979-078
Testosterone 16.2 mg/g · Gel · Transdermal · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Testosterone
- Generic name (nonproprietary)
- testosterone
- Active ingredients
- Testosterone — 16.2 mg/g
- Dosage form
- Gel
- Route
- Transdermal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209390
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 24979-078_183542a9-eb31-4328-9c28-17264a898d03SPL ID 183542a9-eb31-4328-9c28-17264a898d03SPL set ID 10dab294-6a43-4bb3-9d91-2d200c624ffbRxCUI 1597076UNII 3XMK78S47OUPC 0324979078151
- 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. Virilization has been reported in children who were secondarily exposed to testosterone gel ( 5.2 , 6.2 ). Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel ( 2.2 , 5.2 ). Healthcare providers should advise patients to strictly adhere to recommended instructions for use ( 2.2 , 5.2 , 17 ). Testosterone gel 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) ( 1 ) Hypogonadotropic hypogonadism (congenital or …
Excerpt only. Read the full label for complete information.