Carbamazepine
- Product NDC
- 68788-7825
- 11-digit product format
- 687887825
- Labeler code
- 68788
- Product ID
- 68788-7825_f38ba895-3121-4583-98f8-6954ecd2c8e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207798
- Marketing category
- ANDA
- Marketing start
- 2021-01-08
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carbamazepine
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-7825-1 | Carbamazepine | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 68788-7825-3 | Carbamazepine | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 68788-7825-6 | Carbamazepine | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 68788-7825-9 | Carbamazepine | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7825 | CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250215_867a5f4d-8ae6-4339-bbb4-0bf62fb082e5.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 |
|---|
| 68788-7825-1 | 68788782501 | 100 TABLET in 1 BOTTLE (68788-7825-1) | 100 tablet | 2021-01-08 | 0000-00-00 | No | No | Current |
| 68788-7825-3 | 68788782503 | 30 TABLET in 1 BOTTLE (68788-7825-3) | 30 tablet | 2021-01-08 | 0000-00-00 | No | No | Current |
| 68788-7825-6 | 68788782506 | 60 TABLET in 1 BOTTLE (68788-7825-6) | 60 tablet | 2021-01-08 | 0000-00-00 | No | No | Current |
| 68788-7825-9 | 68788782509 | 90 TABLET in 1 BOTTLE (68788-7825-9) | 90 tablet | 2021-01-08 | 0000-00-00 | No | No | Current |