What is NDC 42291-048?

42291-048 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fingolimod NDC 42291-048 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-048Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0048Add 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
42291-048-30	42291004830	30 CAPSULE in 1 BOTTLE (42291-048-30)Marketed from Feb 15, 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: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208008
Marketing start: Feb 15, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers: Product ID 42291-048_484c1f9b-e013-9345-e063-6294a90a7d51SPL ID 484c1f9b-e013-9345-e063-6294a90a7d51SPL set ID 1171df44-48b4-6ef2-e063-6294a90aa121RxCUI 1012895UNII G926EC510TUPC 0342291048300
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

N442291004830 followed by a unit qualifier and the quantity

Package 42291-0048-30. 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 Jan 13, 2026.

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 capsules are 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 42291-048

What is NDC 42291-048?: 42291-048 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by AvKARE. 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?: AvKARE, NDC labeler code 42291. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-227	72205-0227-3072205-0227-32
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	CivicaScript LLC	82249-385	82249-0385-30
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-228	46708-0228-1046708-0228-30
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-228	62332-0228-1062332-0228-30
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	XLCare Pharmaceuticals Inc.	72865-257	72865-0257-30
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Biocon Pharma Inc.	70377-019	70377-0019-1170377-0019-21
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Quallent Pharmaceuticals Health LLC	82009-143	82009-0143-30
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-952	65862-0952-0765862-0952-2865862-0952-30
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Teva Pharmaceuticals, Inc.	0480-7820	00480-7820-56
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	62756-064	62756-0064-5962756-0064-8162756-0064-83+1 more

All 20 Fingolimod NDCs

Other NDCs under ANDA 208008

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

FDA NDC Directory listings under ANDA 208008
Product	Strength	Form · route	Labeler	Product NDC
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Teva Pharmaceuticals, Inc.	0480-7820