Carbamazepine
- Product NDC
- 0615-8545
- 11-digit product format
- 006158545
- Labeler code
- 0615
- Product ID
- 0615-8545_bdd761fd-0c62-4cfb-8155-71cd634e1c86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA074649
- Marketing category
- ANDA
- Marketing start
- 1996-10-03
- 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 |
|---|
| 0615-8545-39 | 00615854539 | 30 TABLET in 1 BLISTER PACK (0615-8545-39) | 30 tablet | 2024-10-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Carbamazepine | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-10-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |