Prescription drug · ANDA
Carbamazepine NDC 70518-4492
Carbamazepine 300 mg/1 · Capsule, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4492-0 | 70518449200 | 30 POUCH in 1 BOX (70518-4492-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4492-1)Marketed from Oct 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)
- Carbamazepine
- Generic name (nonproprietary)
- carbamazepine
- Active ingredients
- Carbamazepine — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078986
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 70518-4492_5b729fad-82e4-5c0b-e063-6394a90ad048SPL ID 5b729fad-82e4-5c0b-e063-6394a90ad048
- Pharmacologic class
- Mood Stabilizer
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
N470518449200followed by a unit qualifier and the quantityPackage 70518-4492-00. 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.
Other NDCs under ANDA 078986
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 |
|---|---|---|---|---|
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-2807 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-2805 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-2806 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2921 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2707 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2706 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-170 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-171 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-172 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3001 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3002 |
| Carbamazepine | Carbamazepine 200 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-6885 |
| Carbamazepine | Carbamazepine 300 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1715 |
| Carbamazepine | Carbamazepine 100 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3077 |