Carbamazepine
- Product NDC
- 70518-4492
- 11-digit product format
- 705184492
- Labeler code
- 70518
- Product ID
- 70518-4492_407d64af-d3f0-7235-e063-6394a90ac39f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078986
- Marketing category
- ANDA
- Marketing start
- 2025-10-06
- Substance
- CARBAMAZEPINE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 33CM23913M | CARBAMAZEPINE | 298-46-4 | CARBAMAZEPINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4492-0 | 70518449200 | 30 POUCH in 1 BOX (70518-4492-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4492-1) | 30 pouch | 2025-10-06 | No | No | Historical |