Prescription drug · ANDA
Eslicarbazepine acetate NDC 31722-431
Eslicarbazepine acetate 800 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-431-30 | 31722043130 | 30 TABLET in 1 BOTTLE (31722-431-30)Marketed from Aug 3, 2023 | |
| 31722-431-32 | 31722043132 | 10 BLISTER PACK in 1 CARTON (31722-431-32) / 10 TABLET in 1 BLISTER PACK (31722-431-31)Marketed from Aug 3, 2023 | |
| 31722-431-90 | 31722043190 | 90 TABLET in 1 BOTTLE (31722-431-90)Marketed from Aug 3, 2023 |
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)
- Eslicarbazepine acetate
- Generic name (nonproprietary)
- eslicarbazepine acetate
- Active ingredients
- Eslicarbazepine acetate — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211186
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 31722-431_35c91221-dff8-9144-e063-6394a90a57fbSPL ID 35c91221-dff8-9144-e063-6394a90a57fbSPL set ID 6200ae2e-ac4e-41b6-a1c3-0ea00703d7e3RxCUI 1482507, 1482515, 1482521, 1482525UNII BEA68ZVB2KUPC 0331722431309, 0331722430906, 0331722428309, 0331722430609, 0331722429306, 0331722431903
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
N431722043130followed by a unit qualifier and the quantityPackage 31722-0431-30. 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)
Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 31722-431
- What is NDC 31722-431?
- 31722-431 is the product NDC for Eslicarbazepine acetate, Eslicarbazepine acetate 800 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eslicarbazepine acetate.
- What is the active ingredient?
- Eslicarbazepine acetate.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eslicarbazepine acetate?
- 35 other product NDCs are listed under this name. See all Eslicarbazepine acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eslicarbazepine acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eslicarbazepine Acetate | Eslicarbazepine acetate 200 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-533 | 59651-0533-30 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-534 | 59651-0534-30 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 600 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-535 | 59651-0535-60 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-536 | 59651-0536-30 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 200 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-717 | 59746-0717-1059746-0717-3059746-0717-90 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 400 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-718 | 59746-0718-1059746-0718-3059746-0718-90 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 600 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-719 | 59746-0719-0559746-0719-3059746-0719-60+1 more |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 800 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-720 | 59746-0720-0559746-0720-3059746-0720-90 |
| Eslicarbazepine acetate | Eslicarbazepine acetate 200 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-538 | 13668-0538-0513668-0538-3013668-0538-60 |
| Eslicarbazepine acetate | Eslicarbazepine acetate 400 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-539 | 13668-0539-0513668-0539-3013668-0539-60 |
Other NDCs under ANDA 211186
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 |
|---|---|---|---|---|
| Eslicarbazepine acetate | Eslicarbazepine acetate 200 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-428 |
| Eslicarbazepine acetate | Eslicarbazepine acetate 400 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-429 |
| Eslicarbazepine acetate | Eslicarbazepine acetate 600 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-430 |