Prescription drug · NDA
Bafiertam (Monomethyl fumarate) NDC 69387-001
Monomethyl fumarate 95 mg/1 · Capsule · Oral · Banner Life Sciences LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69387-001-01 | 69387000101 | 120 CAPSULE in 1 BOTTLE (69387-001-01)Marketed from Apr 28, 2020 |
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)
- Bafiertam
- Generic name (nonproprietary)
- monomethyl fumarate
- Active ingredients
- Monomethyl fumarate — 95 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Banner Life Sciences LLCNDC labeler code 69387
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210296
- Marketing start
- Listing expires
- Identifiers
- Product ID 69387-001_d0b00bc3-b3e0-4cbd-98a2-69d0b5f9a782SPL ID d0b00bc3-b3e0-4cbd-98a2-69d0b5f9a782SPL set ID a161f9d4-70f1-4097-957a-eafb35d3274fRxCUI 2393587, 2393593UNII 45IUB1PX8RUPC 0369387001018
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
N469387000101followed by a unit qualifier and the quantityPackage 69387-0001-01. 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)
BAFIERTAM is 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 adults. BAFIERTAM is 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 adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69387-001
- What is NDC 69387-001?
- 69387-001 is the product NDC for Bafiertam (monomethyl fumarate), Monomethyl fumarate 95 mg/1 capsule, listed with the FDA by Banner Life Sciences LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bafiertam (Monomethyl fumarate).
- What is the active ingredient?
- Monomethyl fumarate.
- Who is the labeler?
- Banner Life Sciences LLC, NDC labeler code 69387. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bafiertam?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.