What is NDC 16729-342?

16729-342 is the product NDC for Fingolimod Hydrochloride, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Accord Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Accord Healthcare Inc., NDC labeler code 16729. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fingolimod Hydrochloride?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fingolimod Hydrochloride NDC 16729-342

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-342Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0342Add 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 NDC	11-digit (billing)	Package	Copy
16729-342-10	1672903421016729034210	30 CAPSULE in 1 BOTTLE (16729-342-10)Marketed from Oct 18, 2022

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): Fingolimod Hydrochloride
Generic name (nonproprietary): fingolimod hydrochloride
Active ingredients: Fingolimod hydrochloride — .5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Accord Healthcare Inc.NDC labeler code 16729
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207991
Marketing start: Oct 18, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers: Product ID 16729-342_4148bb57-7d2c-1724-e063-6294a90a34fdSPL ID 4148bb57-7d2c-1724-e063-6294a90a34fdSPL set ID 65e59a51-c9c2-47b4-84fc-e0f8879eb26cRxCUI 1012895UNII G926EC510T
Pharmacologic class: Sphingosine 1-phosphate Receptor Modulator

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416729034210 followed by a unit qualifier and the quantity

Package 16729-0342-10. 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 Oct 16, 2025.

Indications (excerpt from the label)

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod hydrochloride is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-342

What is NDC 16729-342?: 16729-342 is the product NDC for Fingolimod Hydrochloride, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Accord Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fingolimod Hydrochloride.
What is the active ingredient?: Fingolimod hydrochloride.
Who is the labeler?: Accord Healthcare Inc., NDC labeler code 16729. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fingolimod Hydrochloride?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.