Prescription drug · ANDA
Fingolimod NDC 0480-7820
Fingolimod hydrochloride .5 mg/1 · Capsule · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-7820-56 | 0048078205600480782056 | 30 CAPSULE in 1 BOTTLE (0480-7820-56)Marketed from Feb 14, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208008
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 0480-7820_3add362f-24a1-4f48-a424-86a6cc1ff3e1SPL ID 3add362f-24a1-4f48-a424-86a6cc1ff3e1SPL set ID d9aa1078-fd72-47ef-84b2-2e1ad17b12a2RxCUI 1012895UNII G926EC510TUPC 0304807820565
- 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
N400480782056followed by a unit qualifier and the quantityPackage 00480-7820-56. 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 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.
About NDC 0480-7820
- What is NDC 0480-7820?
- 0480-7820 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals, Inc.. 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?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. 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 | 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 | Sun Pharmaceutical Industries, Inc. | 62756-064 | 62756-0064-5962756-0064-8162756-0064-83+1 more |
Other NDCs under ANDA 208008
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 | AvKARE | 42291-048 |