CARBAMAZEPINE
- Product NDC
- 50268-160
- 11-digit product format
- 502680160
- Labeler code
- 50268
- Product ID
- 50268-160_41156592-01d9-4c4b-e063-6394a90ab9a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA218221
- Marketing category
- ANDA
- Marketing start
- 2025-10-13
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CARBAMAZEPINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMAZEPINE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 308979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-160-11 | CARBAMAZEPINE | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 50268-160-15 | CARBAMAZEPINE | 50 in 1 BOX | TABLET | 50 | | 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 |
|---|
| 50268-160-11 | 50268016011 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-160-15 | 50268016015 | 50 BLISTER PACK in 1 BOX (50268-160-15) / 1 TABLET in 1 BLISTER PACK (50268-160-11) | 50 blister pack | 2025-10-13 | No | No | Current |