Fingolimod NDC 82249-385

NDC codes

FDA NDC Directory

Product NDC (as listed)82249-385Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82249-0385Add 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
82249-385-30	82249038530	30 CAPSULE in 1 BOTTLE (82249-385-30)Marketed from Jun 1, 2026

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
Generic name (nonproprietary): fingolimod
Active ingredients: Fingolimod hydrochloride — .5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: CivicaScript LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208004
Marketing start: Jun 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers: Product ID 82249-385_e1960f9b-f739-452c-b167-245551bf3690SPL ID e1960f9b-f739-452c-b167-245551bf3690SPL set ID e1960f9b-f739-452c-b167-245551bf3690RxCUI 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

N482249038530 followed by a unit qualifier and the quantity

Package 82249-0385-30. 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 May 25, 2026.

Indications (excerpt from the label)

Fingolimod is 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 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)

Other NDCs under ANDA 208004

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

FDA NDC Directory listings under ANDA 208004
Product	Strength	Form · route	Labeler	Product NDC
Fingolimodfingolimod hydrochloride	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-476