What is NDC 43547-003?

43547-003 is the product NDC for Fingolimod, Fingolimod .5 mg/1 capsule, listed with the FDA by Solco Healthcare US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Solco Healthcare US, LLC, NDC labeler code 43547. 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 43547-003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0003Add 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
43547-003-03	43547000303	30 CAPSULE in 1 BOTTLE (43547-003-03)Marketed from Oct 26, 2021
43547-003-09	43547000309	90 CAPSULE in 1 BOTTLE (43547-003-09)Marketed from Oct 26, 2021

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 — .5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Solco Healthcare US, LLCNDC labeler code 43547
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208003
Marketing start: Feb 17, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers: Product ID 43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984SPL ID 8a52d7dc-58d1-4dec-bfbd-5424ec30b984SPL set ID 6c0faf2b-21fb-4830-bb78-5f2dbceb2c82RxCUI 1012895UNII 3QN8BYN5QF
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

N443547000303 followed by a unit qualifier and the quantity

Package 43547-0003-03. 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 Jul 31, 2024.

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 43547-003

What is NDC 43547-003?: 43547-003 is the product NDC for Fingolimod, Fingolimod .5 mg/1 capsule, listed with the FDA by Solco Healthcare US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fingolimod.
What is the active ingredient?: Fingolimod.
Who is the labeler?: Solco Healthcare US, LLC, NDC labeler code 43547. 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	AvKARE	42291-048	42291-0048-30
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Teva Pharmaceuticals, Inc.	0480-7820	00480-7820-56

All 20 Fingolimod NDCs