Prescription drug · NDA
Felbatol (Felbamate) NDC 0037-0430
Felbamate 400 mg/1 · Tablet · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0037-0430-01 | 0003704300100037043001 | 100 TABLET in 1 BOTTLE, PLASTIC (0037-0430-01)Marketed from Jul 29, 1993 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Felbatol
- Generic name (nonproprietary)
- felbamate
- Active ingredients
- Felbamate — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 0037
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020189
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0037-0430_374f8c69-4219-47fd-aeda-8edc73da5411SPL ID 374f8c69-4219-47fd-aeda-8edc73da5411SPL set ID 2f522701-397a-11de-8a39-0800200c9a66RxCUI 198358, 198359, 209026, 209027, 209028, 310285UNII X72RBB02N8
- Pharmacologic class
- Anti-epileptic Agent
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
N400037043001followed by a unit qualifier and the quantityPackage 00037-0430-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Felbatol ® is not indicated as a first line antiepileptic treatment (see Warnings ). Felbatol ® is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk and has provided written acknowledgment, Felbatol ® can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the t…
Excerpt only. Read the full label for complete information.
About NDC 0037-0430
- What is NDC 0037-0430?
- 0037-0430 is the product NDC for Felbatol (felbamate), Felbamate 400 mg/1 tablet, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Felbatol (Felbamate).
- What is the active ingredient?
- Felbamate.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Felbatol?
- 1 other product NDC are listed under this name. See all Felbatol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Felbatol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Felbatolfelbamate | Felbamate 600 mg/1 | TabletOral | Viatris Specialty LLC | 0037-0431 | 00037-0431-01 |
Other NDCs under NDA 020189
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 |
|---|---|---|---|---|
| Felbatolfelbamate | Felbamate 600 mg/1 | TabletOral | Viatris Specialty LLC | 0037-0431 |