Prescription drug · ANDA
Felbamate NDC 72578-057
Felbamate 600 mg/1 · Tablet · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-057-01 | 7257800570172578005701 | 100 TABLET in 1 BOTTLE (72578-057-01)Marketed from Mar 3, 2020 | |
| 72578-057-05 | 7257800570572578005705 | 500 TABLET in 1 BOTTLE (72578-057-05)Marketed from Mar 3, 2020 | |
| 72578-057-06 | 7257800570672578005706 | 30 TABLET in 1 BOTTLE (72578-057-06)Marketed from Mar 3, 2020 | |
| 72578-057-16 | 7257800571672578005716 | 90 TABLET in 1 BOTTLE (72578-057-16)Marketed from Mar 3, 2020 | |
| 72578-057-28 | 7257800572872578005728 | 180 TABLET in 1 BOTTLE (72578-057-28)Marketed from Mar 3, 2020 | |
| 72578-057-77 | 7257800577772578005777 | 10 BLISTER PACK in 1 CARTON (72578-057-77) / 10 TABLET in 1 BLISTER PACK (72578-057-30)Marketed from Mar 3, 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)
- Felbamate
- Generic name (nonproprietary)
- felbamate
- Active ingredients
- Felbamate — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viona Pharmaceuticals IncNDC labeler code 72578
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208970
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 72578-057_e719dd84-3938-4531-871c-4433fec8f4a6SPL ID e719dd84-3938-4531-871c-4433fec8f4a6SPL set ID 96f4357c-720c-4651-b638-7b1181531dc5RxCUI 198358, 198359UNII 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
N472578005701followed by a unit qualifier and the quantityPackage 72578-0057-01. 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 Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP are 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, felbamate 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 a…
Excerpt only. Read the full label for complete information.
About NDC 72578-057
- What is NDC 72578-057?
- 72578-057 is the product NDC for Felbamate, Felbamate 600 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Felbamate.
- What is the active ingredient?
- Felbamate.
- Who is the labeler?
- Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Felbamate?
- 19 other product NDCs are listed under this name. See all Felbamate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Felbamate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Felbamate | Felbamate 400 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-734 | 53746-0734-3053746-0734-90 |
| Felbamate | Felbamate 600 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-735 | 53746-0735-1853746-0735-3053746-0735-90 |
| Felbamate | Felbamate 600 mg/5mL | SuspensionOral | Novitium Pharma LLC | 70954-051 | 70954-0051-1070954-0051-20 |
| Felbamate | Felbamate 400 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-056 | 72578-0056-0172578-0056-0572578-0056-06+2 more |
| Felbamate | Felbamate 400 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-730 | 62559-0730-01 |
| Felbamate | Felbamate 600 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-731 | 62559-0731-01 |
| Felbamate | Felbamate 400 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1937 | 63629-1937-01 |
| Felbamate | Felbamate 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1944 | 63629-1944-01 |
| Felbamate | Felbamate 400 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1770 | 72162-1770-01 |
| Felbamate | Felbamate 600 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1771 | 72162-1771-01 |
Other NDCs under ANDA 208970
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 |
|---|---|---|---|---|
| Felbamate | Felbamate 400 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1077 |
| Felbamate | Felbamate 600 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1078 |
| Felbamate | Felbamate 400 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-056 |