Prescription drug · ANDA
Carbamazepine NDC 50268-172
Carbamazepine 300 mg/1 · Capsule, Extended release · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-172-13 | 50268017213 | 30 BLISTER PACK in 1 BOX (50268-172-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-172-11)Marketed from Oct 19, 2021 |
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)
- Carbamazepine
- Generic name (nonproprietary)
- carbamazepine
- Active ingredients
- Carbamazepine — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- AvPAK
- 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 50268-172_47e2efaa-df8e-5401-e063-6394a90aae6cSPL ID 47e2efaa-df8e-5401-e063-6394a90aae6cSPL set ID ceb84aa4-2041-6e6e-e053-2995a90a0f24RxCUI 200131, 200133, 388311UNII 33CM23913M
- 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
N450268017213followed by a unit qualifier and the quantityPackage 50268-0172-13. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | REMEDYREPACK INC. | 70518-4492 |
| 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 | 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 |