Prescription drug · ANDA
Fingolimod NDC 82009-143
Fingolimod hydrochloride .5 mg/1 · Capsule · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-143-30 | 8200901433082009014330 | 30 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
N482009014330followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Fingolimod products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 |
| Fingolimod | Fingolimod hydrochloride .5 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-064 | 62756-0064-5962756-0064-8162756-0064-83+1 more |
Other NDCs under ANDA 207979
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fingolimod | Fingolimod hydrochloride .5 mg/1 | CapsuleOral | Biocon Pharma Inc. | 70377-019 |