Carbamazepine
- Product NDC
- 0904-6885
- 11-digit product format
- 009046885
- Labeler code
- 0904
- Product ID
- 0904-6885_7104f25b-547e-4163-b1c9-e3cb5831ff5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078986
- Marketing category
- ANDA
- Marketing start
- 2012-03-23
- 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 | 200133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6885-04 | Carbamazepine | 30 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 30 | | 5 |
| 0904-6885-04 | Carbamazepine | 1 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6885 | CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250402_2676f950-48b4-4bef-a792-ea4570de9aa6.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 |
|---|
| 0904-6885-04 | 00904688504 | 30 BLISTER PACK in 1 CARTON (0904-6885-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK | 30 blister pack | 2012-03-23 | 0000-00-00 | No | No | Current |