Carbamazepine
- Product NDC
- 0781-8016
- 11-digit product format
- 007818016
- Labeler code
- 0781
- Product ID
- 0781-8016_7a606a30-c4f8-4694-9642-edb8e3cf5eee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- NDA020234
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1996-03-25
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
| DEXTRATES | INACTIVE INGREDIENT | G263MI44RU | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-8016 | CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC] | 23 | Legacy NDC | 20221208_3a3344dc-9cc8-41da-859e-295d053597c1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-8016-01 | 00781801601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8016-01) | 2018-01-09 | 0000-00-00 | No | No | Current |