Carbamazepine
- Product NDC
- 67877-798
- 11-digit product format
- 678770798
- Labeler code
- 67877
- Product ID
- 67877-798_f712b540-b6b2-4fc7-a7b4-38b3a8e51964
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA217277
- Marketing category
- ANDA
- Marketing start
- 2025-11-01
- Substance
- CARBAMAZEPINE
- Active strength
- 200 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 |
|---|
| 67877-798-01 | 67877079801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-798-01) | | 2025-11-01 | No | No | Historical |
| 67877-798-05 | 67877079805 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-798-05) | | 2025-11-01 | No | No | Historical |
| 67877-798-30 | 67877079830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-798-30) | | 2025-11-01 | No | No | Historical |
| 67877-798-33 | 67877079833 | 1 BLISTER PACK in 1 CARTON (67877-798-33) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2025-11-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Carbamazepine | Ascend Laboratories, LLC | Alkem Laboratories Limited | 2025-11-03 | Human Prescription Drug Label | 5 |