Prescription drug · ANDA
Fingolimod NDC 65862-952
Fingolimod hydrochloride .5 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-952-07 | 65862095207 | 1 BLISTER PACK in 1 CARTON (65862-952-07) / 7 CAPSULE in 1 BLISTER PACKMarketed from Feb 28, 2024 | |
| 65862-952-28 | 65862095228 | 4 BLISTER PACK in 1 CARTON (65862-952-28) / 7 CAPSULE in 1 BLISTER PACKMarketed from Feb 28, 2024 | |
| 65862-952-30 | 65862095230 | 30 CAPSULE in 1 BOTTLE (65862-952-30)Marketed from Feb 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
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207983
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 65862-952_067884b9-a619-48da-a4b2-225dce025421SPL ID 067884b9-a619-48da-a4b2-225dce025421SPL set ID d6301307-55c6-4b91-a505-ff93c865f859RxCUI 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
N465862095207followed by a unit qualifier and the quantityPackage 65862-0952-07. 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 65862-952
- What is NDC 65862-952?
- 65862-952 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 | 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 |