Prescription drug · ANDA
Eslicarbazepine Acetate NDC 60505-4658
Eslicarbazepine acetate 200 mg/1 · Tablet · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4658-3 | 6050546580360505465803 | 30 TABLET in 1 BOTTLE (60505-4658-3)Marketed from May 6, 2025 | |
| 60505-4658-9 | 6050546580960505465809 | 90 TABLET in 1 BOTTLE (60505-4658-9)Marketed from May 6, 2025 |
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)
- Eslicarbazepine Acetate
- Generic name (nonproprietary)
- eslicarbazepine acetate
- Active ingredients
- Eslicarbazepine acetate — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211236
- 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 60505-4658_ce7f0fa9-9973-64fc-b9db-9f4edc82a224SPL ID ce7f0fa9-9973-64fc-b9db-9f4edc82a224
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
N460505465803followed by a unit qualifier and the quantityPackage 60505-4658-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-4658
- What is NDC 60505-4658?
- 60505-4658 is the product NDC for Eslicarbazepine Acetate, Eslicarbazepine acetate 200 mg/1 tablet, listed with the FDA by Apotex Corp.. It has 2 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?
- Apotex Corp., NDC labeler code 60505. 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 211236
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 | Golden State Medical Supply, Inc. | 51407-779 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-780 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 600 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-781 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 800 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-782 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 400 mg/1 | TabletOral | Apotex Corp. | 60505-4659 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 600 mg/1 | TabletOral | Apotex Corp. | 60505-4660 |
| Eslicarbazepine Acetate | Eslicarbazepine acetate 800 mg/1 | TabletOral | Apotex Corp. | 60505-4661 |