Prescription drug · ANDA
Testosterone NDC 68180-941
Testosterone 16.2 mg/g · Gel · Transdermal · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-941-11 | 68180094111 | 1 BOTTLE, PUMP in 1 CARTON (68180-941-11) / 88 g in 1 BOTTLE, PUMPMarketed from Apr 10, 2019 |
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)
- Testosterone
- Generic name (nonproprietary)
- testosterone
- Active ingredients
- Testosterone — 16.2 mg/g
- Dosage form
- Gel
- Route
- Transdermal
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208560
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 68180-941_b49d821a-a323-42d4-912a-7c673e813b36SPL ID b49d821a-a323-42d4-912a-7c673e813b36SPL set ID 61387416-510d-40c5-9e2d-24bfb7f56d08RxCUI 1597076UNII 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
N468180094111followed by a unit qualifier and the quantityPackage 68180-0941-11. 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 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 acquired) ( 1 ) Limitations of use: Safety and efficacy of testosterone gel 1.62% in men with "age-related hypogonadism" have not been established. ( 1 ) Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established. ( 1 , 8.4 ) Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. ( 1 , 12.3 ) Testosterone gel 1.62% i…
Excerpt only. Read the full label for complete information.