CARBAMAZEPINE
- Product NDC
- 0904-3854
- 11-digit product format
- 009043854
- Labeler code
- 0904
- Product ID
- 0904-3854_4da43d38-dcd6-4447-8693-5e41e78aacbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075712
- Marketing category
- ANDA
- Marketing start
- 2010-03-22
- 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
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 308973, 308979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-3854-61 | CARBAMAZEPINE | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 27 |
| 0904-3854-61 | CARBAMAZEPINE | 100 in 1 CARTON | TABLET, CHEWABLE | 100 | | 27 |
| 0904-3854-80 | CARBAMAZEPINE | 1000 in 1 BOTTLE | TABLET, CHEWABLE | 1000 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-3854 | CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET [MAJOR PHARMACEUTICALS] | 24 | Current NDC, Legacy NDC, 3 package rows | 20250507_2a8c7366-ce89-47ce-8123-96f26812fca0.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 |
|---|
| 0904-3854-61 | 00904385461 | 100 BLISTER PACK in 1 CARTON (0904-3854-61) / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 100 blister pack | 2010-03-22 | 0000-00-00 | No | No | Current |
| 0904-3854-80 | 00904385480 | 1000 TABLET, CHEWABLE in 1 BOTTLE (0904-3854-80) | | 2010-03-22 | 0000-00-00 | No | No | Current |