Prescription drug · ANDA
testosterone NDC 72162-1421
Testosterone 30 mg/1.5mL · Solution · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1421-2 | 72162142102 | 1 BOTTLE, PUMP in 1 CARTON (72162-1421-2) / 110 mL in 1 BOTTLE, PUMPMarketed from Jan 11, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 30 mg/1.5mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204255
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 72162-1421_78ca5df2-0a66-41fe-9f28-4ba270cfce81SPL ID 78ca5df2-0a66-41fe-9f28-4ba270cfce81SPL set ID 5be74193-de73-436d-a9a1-35a857bc8e0cRxCUI 1599949UNII 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
N472162142102followed by a unit qualifier and the quantityPackage 72162-1421-02. 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 Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as 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 (FSH, LH) above the normal range. • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury fr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204255
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 |
|---|---|---|---|---|
| testosterone | Testosterone 30 mg/1.5mL | SolutionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-610 |
| testosterone | Testosterone 30 mg/1.5mL | SolutionTopical | Bryant Ranch Prepack | 63629-9310 |