What is NDC 70771-1603?

70771-1603 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1603 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1603Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1603Add 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
70771-1603-1	70771160301	100 CAPSULE in 1 BOTTLE (70771-1603-1)Marketed from Oct 11, 2022
70771-1603-3	70771160303	30 CAPSULE in 1 BOTTLE (70771-1603-3)Marketed from Oct 11, 2022
70771-1603-7	70771160307	1 BLISTER PACK in 1 CARTON (70771-1603-7) / 7 CAPSULE in 1 BLISTER PACKMarketed from Oct 11, 2022
70771-1603-8	70771160308	4 BLISTER PACK in 1 CARTON (70771-1603-8) / 7 CAPSULE in 1 BLISTER PACKMarketed from Oct 11, 2022
70771-1603-9	70771160309	90 CAPSULE in 1 BOTTLE (70771-1603-9)Marketed from Oct 11, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207994
Marketing start: Oct 11, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers: Product ID 70771-1603_423dd0fd-c654-4de1-b535-947cd795758bSPL ID 423dd0fd-c654-4de1-b535-947cd795758bSPL set ID 5a0319b4-4bc6-4564-9687-9cfd5c1b23a8RxCUI 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

N470771160301 followed by a unit qualifier and the quantity

Package 70771-1603-01. 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 Nov 30, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1603

What is NDC 70771-1603?: 70771-1603 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 5 package NDCs, 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?: Zydus Lifesciences Limited, NDC labeler code 70771. 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

Other NDCs under ANDA 207994

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

FDA NDC Directory listings under ANDA 207994
Product	Strength	Form · route	Labeler	Product NDC
Fingolimod	Fingolimod hydrochloride .5 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	68382-912