Prescription drug · ANDA
fingolimod (Fingolimod hcl) NDC 64980-449
Fingolimod hydrochloride .5 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-449-03 | 64980044903 | 30 CAPSULE in 1 BOTTLE (64980-449-03)Marketed from Sep 4, 2023 |
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 hcl
- Active ingredients
- Fingolimod hydrochloride — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207939
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 64980-449_2622c15a-3781-3016-e063-6294a90a84d5SPL ID 2622c15a-3781-3016-e063-6294a90a84d5SPL set ID 99e7daf4-ea90-5e47-e053-2a95a90ac1b7RxCUI 1012895UNII G926EC510TUPC 0364980449038
- 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
N464980044903followed by a unit qualifier and the quantityPackage 64980-0449-03. 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 .
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 64980-449
- What is NDC 64980-449?
- 64980-449 is the product NDC for fingolimod (fingolimod hcl), Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- fingolimod (Fingolimod hcl).
- What is the active ingredient?
- Fingolimod hydrochloride.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 | Teva Pharmaceuticals, Inc. | 0480-7820 | 00480-7820-56 |