NDC codes

FDA NDC Directory
Product NDC (as listed)24979-078Labeler and product segments. Claims need a package NDC.
Product NDC at billing width24979-0078Add the package segment from the table below.

Product information

Brand name (proprietary)
Testosterone
Generic name (nonproprietary)
testosterone
Active ingredients
Testosterone — 16.2 mg/g
Dosage form
Gel
Route
Transdermal
Labeler
Upsher-Smith Laboratories, LLCNDC labeler code 24979
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209390
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 24979-078_183542a9-eb31-4328-9c28-17264a898d03SPL ID 183542a9-eb31-4328-9c28-17264a898d03SPL set ID 10dab294-6a43-4bb3-9d91-2d200c624ffbRxCUI 1597076UNII 3XMK78S47OUPC 0324979078151
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.

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. Virilization has been reported in children who were secondarily exposed to testosterone gel ( 5.2 , 6.2 ). Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel ( 2.2 , 5.2 ). Healthcare providers should advise patients to strictly adhere to recommended instructions for use ( 2.2 , 5.2 , 17 ). 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 24979-078

What is NDC 24979-078?
24979-078 is the product NDC for Testosterone, Testosterone 16.2 mg/g gel, listed with the FDA by Upsher-Smith Laboratories, LLC.
What drug is associated with this NDC?
Testosterone.
What is the active ingredient?
Testosterone.
Who is the labeler?
Upsher-Smith Laboratories, LLC, NDC labeler code 24979. 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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