NDC codes

FDA NDC Directory
Product NDC (as listed)0591-2924Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00591-2924Add 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
0591-2924-1800591292418005912924181 BOTTLE, PUMP in 1 CARTON (0591-2924-18) / 88 g in 1 BOTTLE, PUMPMarketed from Apr 10, 2019

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
Testosterone — 16.2 mg/g
Dosage form
Gel
Route
Transdermal
Labeler
Actavis Pharma, Inc.NDC labeler code 0591
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204570
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 0591-2924_b63936d3-2d0c-4a45-8096-2d5c672e3819SPL ID b63936d3-2d0c-4a45-8096-2d5c672e3819SPL set ID 4f3c2c0a-7dab-4b50-9cae-869c3c2a8498RxCUI 1597076, 1597120, 1597126UNII 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

N400591292418 followed by a unit qualifier and the quantity

Package 00591-2924-18. 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 adult 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 (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0591-2924

What is NDC 0591-2924?
0591-2924 is the product NDC for Testosterone, Testosterone 16.2 mg/g gel, listed with the FDA by Actavis Pharma, 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?
Actavis Pharma, Inc., NDC labeler code 0591. 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

Other NDCs under ANDA 204570

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

FDA NDC Directory listings under ANDA 204570
ProductStrengthForm · routeLabelerProduct NDC
TestosteroneTestosterone 16.2 mg/gGelTransdermalActavis Pharma, Inc.0591-2926

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