Prescription drug · ANDA
Fingolimod (fingolimod hydrochloride) NDC 67877-476
Fingolimod hydrochloride .5 mg/1 · Capsule · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-476-30 | 67877047630 | 30 CAPSULE in 1 BOTTLE (67877-476-30)Marketed from Sep 21, 2022 | |
| 67877-476-32 | 67877047632 | 7 BLISTER PACK in 1 CARTON (67877-476-32) / 7 CAPSULE in 1 BLISTER PACKMarketed from Sep 21, 2022 | |
| 67877-476-33 | 67877047633 | 10 BLISTER PACK in 1 CARTON (67877-476-33) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 21, 2022 | |
| 67877-476-56 | 67877047656 | 28 CAPSULE in 1 BOTTLE (67877-476-56)Marketed from Sep 21, 2022 | |
| 67877-476-58 | 67877047658 | 28 BLISTER PACK in 1 CARTON (67877-476-58) / 14 CAPSULE in 1 BLISTER PACK (67877-476-14)Marketed from Sep 21, 2022 |
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 hydrochloride
- Active ingredients
- Fingolimod hydrochloride — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208004
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 67877-476_d2f337fa-908a-4ae9-bcfd-59dcc4353705SPL ID d2f337fa-908a-4ae9-bcfd-59dcc4353705SPL set ID 0f638feb-6986-41e4-8f9c-2e6b84a5bb44RxCUI 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
N467877047630followed by a unit qualifier and the quantityPackage 67877-0476-30. 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 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.
Other NDCs under ANDA 208004
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 | CivicaScript LLC | 82249-385 |