NDC codes

FDA NDC Directory
Product NDC (as listed)68180-943Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0943Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68180-943-11681800943111 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
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

N468180094311 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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