NDC codes

FDA NDC Directory
Product NDC (as listed)0832-1121Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00832-1121Add 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
0832-1121-42008321121422 BOTTLE, PUMP in 1 CARTON (0832-1121-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40)Marketed from Jun 16, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Testosterone12.5 mg/1
Dosage form
Gel, Metered
Route
Topical
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 204399
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 0832-1121_39853cd7-bfd1-848f-e063-6294a90a49e4SPL ID 39853cd7-bfd1-848f-e063-6294a90a49e4SPL set ID a887020f-b41f-49fe-8379-f01147b2a796RxCUI 1596780, 1597129UNII 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

N400832112142 followed by a unit qualifier and the quantity

Package 00832-1121-42. 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 is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypotha

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204399

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 204399
ProductStrengthForm · routeLabelerProduct NDC
VogelxotestosteroneTestosterone 50 mg/5gGelTopicalUpsher-Smith Laboratories, LLC0245-0871
VogelxotestosteroneTestosterone 12.5 mg/1Gel, MeteredTopicalUpsher-Smith Laboratories, LLC0245-0872
TestosteroneTestosterone 50 mg/5gGelTopicalUpsher-Smith Laboratories, LLC0832-1120

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