Carbamazepine
- Product NDC
- 75834-220
- 11-digit product format
- 758340220
- Labeler code
- 75834
- Product ID
- 75834-220_45806c19-4811-987e-e063-6394a90aa8fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NIVAGEN PHARMACEUTICALS, INC.
- Application
- ANDA207798
- Marketing category
- ANDA
- Marketing start
- 2020-04-21
- Substance
- CARBAMAZEPINE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 197441, 308979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-220-00 | Carbamazepine | 1000 in 1 BOTTLE | TABLET | 1000 | | 20 |
| 75834-220-01 | Carbamazepine | 100 in 1 BOTTLE | TABLET | 100 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-220 | CARBAMAZEPINE TABLET [NIVAGEN PHARMACEUTICALS, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241225_e68998cb-5f91-4d7e-85a6-555efb8b0384.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-220-00 | 75834022000 | 1000 TABLET in 1 BOTTLE (75834-220-00) | 1000 tablet | 2020-04-21 | 0000-00-00 | No | No | Current |
| 75834-220-01 | 75834022001 | 100 TABLET in 1 BOTTLE (75834-220-01) | 100 tablet | 2020-04-21 | 0000-00-00 | No | No | Current |