NDC codes

FDA NDC Directory
Product NDC (as listed)68180-941Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0941Add 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
68180-941-1168180094111681800941111 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.NDC labeler code 68180
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

N468180094111 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 68180-941

What is NDC 68180-941?
68180-941 is the product NDC for Testosterone, Testosterone 16.2 mg/g gel, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Testosterone.
What is the active ingredient?
Testosterone.
Who is the labeler?
Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Testosterone?
42 other product NDCs are listed under this name. See all Testosterone NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Testosterone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TestosteroneTestosterone 30 mg/1.5mLSolutionTopicalEncube Ethicals, Inc.21922-10921922-0109-16
TestosteroneTestosterone 25 mg/2.5gGelTransdermalPrasco Laboratories66993-95466993-0954-30
TestosteroneTestosterone 16.2 mg/gGelTransdermalPrasco Laboratories66993-95166993-0951-88
TestosteroneTestosterone 16.2 mg/gGelTransdermalPrasco Laboratories66993-95266993-0952-30
TestosteroneTestosterone 12.5 mg/1.25gGelTransdermalPrasco Laboratories66993-95366993-0953-44
TestosteroneTestosterone 50 mg/5gGelTransdermalPrasco Laboratories66993-95566993-0955-30
TestosteroneTestosterone 30 [hp_X]/1TabletOralZoe Processing44117-000344117-0003-01
TestosteroneTestosterone 16.2 mg/gGelTransdermalEncube Ethicals, Inc.21922-03021922-0030-2021922-0030-52
TestosteroneTestosterone 20.25 mg/1.25gGel, MeteredTransdermalNorthstar Rx LLC72603-26572603-0265-01
TestosteroneTestosterone 25 mg/2.5gGelTransdermalStrides Pharma Science Limited64380-15164380-0151-02

All 43 Testosterone NDCs

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