Prescription drug · ANDA
Fingolimod NDC 60505-4332
Fingolimod hydrochloride .5 mg/1 · Capsule · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4332-3 | 6050543320360505433203 | 30 CAPSULE in 1 BOTTLE (60505-4332-3)Marketed from Oct 18, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207993
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 60505-4332_86f5b63a-34af-9193-cf6a-91dec20bd8b3SPL ID 86f5b63a-34af-9193-cf6a-91dec20bd8b3
- 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
N460505433203followed by a unit qualifier and the quantityPackage 60505-4332-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-4332
- What is NDC 60505-4332?
- 60505-4332 is the product NDC for Fingolimod, Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Apotex Corp.. 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?
- Apotex Corp., NDC labeler code 60505. 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 |
Other NDCs under ANDA 207993
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 | Novadoz Pharmaceuticals LLC | 72205-227 |