CARBAMAZEPINE
- Product NDC
- 46708-731
- 11-digit product format
- 467080731
- Labeler code
- 46708
- Product ID
- 46708-731_a742c03d-10b1-48e2-8df1-48967395ae06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216623
- Marketing category
- ANDA
- Marketing start
- 2024-12-31
- 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 |
|---|
| 46708-731-10 | 46708073110 | 100 BLISTER PACK in 1 CARTON (46708-731-10) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2025-04-22 | No | No | Historical |
| 46708-731-31 | 46708073131 | 100 TABLET in 1 BOTTLE (46708-731-31) | 100 tablet | 2025-04-22 | No | No | Historical |
| 46708-731-60 | 46708073160 | 60 TABLET in 1 BOTTLE (46708-731-60) | 60 tablet | 2025-04-22 | No | No | Historical |
| 46708-731-91 | 46708073191 | 1000 TABLET in 1 BOTTLE (46708-731-91) | 1000 tablet | 2025-04-22 | No | No | Historical |