Carbamazepine
- Product NDC
- 68999-802
- 11-digit product format
- 689990802
- Labeler code
- 68999
- Product ID
- 68999-802_41dd08a0-b89b-6ad3-e063-6394a90afdc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC.
- Application
- ANDA075714
- Marketing category
- ANDA
- Marketing start
- 2002-06-05
- Substance
- CARBAMAZEPINE
- Active strength
- 100 mg/5mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carbamazepine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMAZEPINE | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 308976 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68999-802-24 | Carbamazepine | 2 in 1 BOX | SUSPENSION | 2 | | 1 |
| 68999-802-24 | Carbamazepine | 10 in 1 TRAY | SUSPENSION | 10 | | 1 |
| 68999-802-45 | Carbamazepine | 5 mL in 1 CUP | SUSPENSION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68999-802-24 | 68999080224 | 2 TRAY in 1 BOX (68999-802-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-802-45) | 2 tray | 2025-10-15 | No | No | Current |
| 68999-802-45 | 68999080245 | 5 mL in 1 CUP | 5 ml | | | | Historical |