Carbamazepine
- Product NDC
- 0904-7116
- 11-digit product format
- 009047116
- Labeler code
- 0904
- Product ID
- 0904-7116_9e970e7f-4af3-43cf-91fa-409c08dc4719
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076729
- Marketing category
- ANDA
- Marketing start
- 2004-09-20
- Marketing end
- 0000-00-00
- Substance
- CARBAMAZEPINE
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7116 | CARBAMAZEPINE SUSPENSION [MAJOR PHARMACEUTICALS] | 2 | Legacy NDC | 20240906_9e970e7f-4af3-43cf-91fa-409c08dc4719.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7116-01 | 00904711601 | 30 CUP in 1 CASE (0904-7116-01) > 10 mL in 1 CUP (0904-7116-66) | 30 cup | 2004-09-20 | 0000-00-00 | No | No | Current |