Prescription drug · ANDA
Testosterone NDC 68180-943
Testosterone 30 mg/1.5mL · Solution · Topical · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-943-11 | 68180094311 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68180-943-11) / 90 mL in 1 BOTTLE, WITH APPLICATORMarketed from Feb 23, 2018 |
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 — 30 mg/1.5mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208061
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 68180-943_0ed3a7bc-bbb1-4cc3-9d09-b09c0c4e8892SPL ID 0ed3a7bc-bbb1-4cc3-9d09-b09c0c4e8892SPL set ID 29c8846f-121c-4958-9e03-3bd271c21558RxCUI 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
N468180094311followed by a unit qualifier and the quantityPackage 68180-0943-11. 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 topical solution USP 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 topical solution USP in men with "age-related hypogonadism" have not been established. ( 1 ) Safety and efficacy of testosterone topical solution USP in males <18 years old have not been established ( 8.4 ) Testosterone topical solution USP is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone…
Excerpt only. Read the full label for complete information.