NDC codes

FDA NDC Directory
Product NDC (as listed)16714-968Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0968Add 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
16714-968-02167140968021671409680230 PACKET in 1 CARTON (16714-968-02) / 1.25 g in 1 PACKET (16714-968-01)Marketed from Nov 6, 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 — 20.25 mg/1.25g
Dosage form
Gel
Route
Topical
Labeler
Northstar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205781
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 16714-968_69926316-dfe4-4060-a58b-36e431d571cfSPL ID 69926316-dfe4-4060-a58b-36e431d571cfSPL set ID 2d55b825-8eab-4091-bdf2-9c52d111b8ebRxCUI 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416714096802 followed by a unit qualifier and the quantity

Package 16714-0968-02. 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 16714-968

What is NDC 16714-968?
16714-968 is the product NDC for testosterone, Testosterone 20.25 mg/1.25g gel, listed with the FDA by Northstar Rx LLC. 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?
Northstar Rx LLC, NDC labeler code 16714. 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 205781

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

FDA NDC Directory listings under ANDA 205781
ProductStrengthForm · routeLabelerProduct NDC
testosteroneTestosterone 40.5 mg/2.5gGelTopicalNorthstar Rx LLC16714-969
testosteroneTestosterone 20.25 mg/1.25gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-281
testosteroneTestosterone 40.5 mg/2.5gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-366

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