Prescription drug · ANDA
Felbamate NDC 70771-1078
Felbamate 600 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1078-1 | 70771107801 | 100 TABLET in 1 BOTTLE (70771-1078-1)Marketed from Aug 15, 2017 | |
| 70771-1078-3 | 70771107803 | 30 TABLET in 1 BOTTLE (70771-1078-3)Marketed from Aug 15, 2017 | |
| 70771-1078-4 | 70771107804 | 10 BLISTER PACK in 1 CARTON (70771-1078-4) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 15, 2017 | |
| 70771-1078-5 | 70771107805 | 500 TABLET in 1 BOTTLE (70771-1078-5)Marketed from Aug 15, 2017 | |
| 70771-1078-8 | 70771107808 | 180 TABLET in 1 BOTTLE (70771-1078-8)Marketed from Aug 15, 2017 | |
| 70771-1078-9 | 70771107809 | 90 TABLET in 1 BOTTLE (70771-1078-9)Marketed from Aug 15, 2017 |
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)
- Felbamate
- Generic name (nonproprietary)
- felbamate
- Active ingredients
- Felbamate — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- 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 70771-1078_785f1747-e29d-432a-82e7-fcaeea202327SPL ID 785f1747-e29d-432a-82e7-fcaeea202327SPL set ID efa55cb2-b625-4392-9ddb-0a8ad8ee58c4RxCUI 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
N470771107801followed by a unit qualifier and the quantityPackage 70771-1078-01. 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 .
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 | Viona Pharmaceuticals Inc | 72578-056 |
| Felbamate | Felbamate 600 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-057 |
| Felbamate | Felbamate 400 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1077 |