NDC codes

FDA NDC Directory
Product NDC (as listed)82009-143Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0143Add 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
82009-143-30820090143308200901433030 CAPSULE in 1 BOTTLE (82009-143-30)Marketed from Mar 28, 2024

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
Quallent Pharmaceuticals Health LLCNDC labeler code 82009
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207979
Marketing start
Listing expires
Other FDA classes
Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers
Product ID 82009-143_552e23c9-15d0-e67e-5367-43c702f010f6SPL ID 552e23c9-15d0-e67e-5367-43c702f010f6SPL set ID 5434bd4a-2610-0e17-4f14-513ff1cbb822RxCUI 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

N482009014330 followed by a unit qualifier and the quantity

Package 82009-0143-30. 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 .

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 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 82009-143

What is NDC 82009-143?
82009-143 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fingolimod.
What is the active ingredient?
Fingolimod hydrochloride.
Who is the labeler?
Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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?
19 other product NDCs are listed under this name. See all Fingolimod 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 Fingolimod NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralNovadoz Pharmaceuticals LLC72205-22772205-0227-3072205-0227-32
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralCivicaScript LLC82249-38582249-0385-30
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-22846708-0228-1046708-0228-30
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-22862332-0228-1062332-0228-30
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralXLCare Pharmaceuticals Inc.72865-25772865-0257-30
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralBiocon Pharma Inc.70377-01970377-0019-1170377-0019-21
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralAurobindo Pharma Limited65862-95265862-0952-0765862-0952-2865862-0952-30
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralAvKARE42291-04842291-0048-30
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralTeva Pharmaceuticals, Inc.0480-782000480-7820-56
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.62756-06462756-0064-5962756-0064-8162756-0064-83+1 more

All 20 Fingolimod NDCs

Other NDCs under ANDA 207979

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

FDA NDC Directory listings under ANDA 207979
ProductStrengthForm · routeLabelerProduct NDC
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralBiocon Pharma Inc.70377-019

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in