NDC codes

FDA NDC Directory
Product NDC (as listed)60505-4332Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-4332Add 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
60505-4332-3605054332036050543320330 CAPSULE in 1 BOTTLE (60505-4332-3)Marketed from Oct 18, 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
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207993
Marketing start
Listing expires
Other FDA classes
Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers
Product ID 60505-4332_86f5b63a-34af-9193-cf6a-91dec20bd8b3SPL ID 86f5b63a-34af-9193-cf6a-91dec20bd8b3
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

N460505433203 followed by a unit qualifier and the quantity

Package 60505-4332-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-4332

What is NDC 60505-4332?
60505-4332 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Apotex Corp.. 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?
Apotex Corp., NDC labeler code 60505. 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/1CapsuleOralQuallent Pharmaceuticals Health LLC82009-14382009-0143-30
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

All 20 Fingolimod NDCs

Other NDCs under ANDA 207993

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

FDA NDC Directory listings under ANDA 207993
ProductStrengthForm · routeLabelerProduct NDC
FingolimodFingolimod hydrochloride .5 mg/1CapsuleOralNovadoz Pharmaceuticals LLC72205-227

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