Prescription drug · ANDA
Eslicarbazepine Acetate NDC 43598-686
Eslicarbazepine acetate 600 mg/1 · Tablet · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-686-60 | 43598068660 | 60 TABLET in 1 BOTTLE (43598-686-60)Marketed from May 6, 2025 | |
| 43598-686-90 | 43598068690 | 90 TABLET in 1 BOTTLE (43598-686-90)Marketed from May 6, 2025 |
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 — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211238
- 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 43598-686_75484338-6d78-877c-086f-61467c8dd5e4SPL ID 75484338-6d78-877c-086f-61467c8dd5e4SPL set ID 190fccbc-da3f-b175-ac02-f2c4307a15c3RxCUI 1482507, 1482515, 1482521, 1482525UNII BEA68ZVB2K
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
N443598068660followed by a unit qualifier and the quantityPackage 43598-0686-60. 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.
Other NDCs under ANDA 211238
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 400 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-685 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 200 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-684 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 800 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-687 |