CARBAMAZEPINE
- Product NDC
- 60687-583
- 11-digit product format
- 606870583
- Labeler code
- 60687
- Product ID
- 60687-583_33789d2e-f734-3430-e063-6294a90a71d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA211623
- Marketing category
- ANDA
- Marketing start
- 2022-01-05
- 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 |
|---|
| 60687-583-21 | 60687058321 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-583-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-583-11) | 30 blister pack | 2022-01-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| CARBAMAZEPINE | American Health Packaging | 2025-04-23 | HUMAN PRESCRIPTION DRUG LABEL | 3 |