CARBAMAZEPINE
- Product NDC
- 43353-953
- 11-digit product format
- 433530953
- Labeler code
- 43353
- Product ID
- 43353-953_7c7b8491-2291-48de-8b76-bf2eca6c9d9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075948
- Marketing category
- ANDA
- Marketing start
- 2014-03-07
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CARBAMAZEPINE
- Listing expiration
- 2026-12-31
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 |
|---|
| 43353-953-53 | CARBAMAZEPINE | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 43353-953-60 | CARBAMAZEPINE | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 43353-953-80 | CARBAMAZEPINE | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-953 | CARBAMAZEPINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20160708_c1fc31ef-6b2e-4de4-a185-ec44e94e7b40.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 |
|---|
| 43353-953-53 | 43353095353 | 60 TABLET in 1 BOTTLE (43353-953-53) | 60 tablet | 2014-07-03 | 0000-00-00 | No | No | Current |
| 43353-953-60 | 43353095360 | 90 TABLET in 1 BOTTLE (43353-953-60) | 90 tablet | 2014-07-03 | 0000-00-00 | No | No | Current |
| 43353-953-80 | 43353095380 | 180 TABLET in 1 BOTTLE (43353-953-80) | 180 tablet | 2014-07-25 | 0000-00-00 | No | No | Current |