NDC codes

FDA NDC Directory
Product NDC (as listed)62332-488Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0488Add 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
62332-488-1162332048811623320488111 BOTTLE, WITH APPLICATOR in 1 CARTON (62332-488-11) / 110 mL in 1 BOTTLE, WITH APPLICATORMarketed from Dec 8, 2021

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
Alembic Pharmaceuticals Inc.NDC labeler code 62332
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212882
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 62332-488_5ce13b01-78d1-49fa-80c9-6e54d0774e14SPL ID 5ce13b01-78d1-49fa-80c9-6e54d0774e14SPL set ID e39289aa-681c-47ec-9461-52e7f17e5d71RxCUI 1599949UNII 3XMK78S47OUPC 0362332488117
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

N462332048811 followed by a unit qualifier and the quantity

Package 62332-0488-11. 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 is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as 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 concentrations and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62332-488

What is NDC 62332-488?
62332-488 is the product NDC for Testosterone, Testosterone 30 mg/1.5mL solution, listed with the FDA by Alembic 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?
Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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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