Carbamazepine
- Product NDC
- 0615-8125
- 11-digit product format
- 006158125
- Labeler code
- 0615
- Product ID
- 0615-8125_f8c0c630-dec1-4c2b-9925-39f6a3c86909
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA075687
- Marketing category
- ANDA
- Marketing start
- 2000-10-24
- 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
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 308973 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8125-39 | Carbamazepine | 30 in 1 BLISTER PACK | TABLET, CHEWABLE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8125 | CARBAMAZEPINE TABLET, CHEWABLE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20220818_963db7cf-e9f5-496c-816e-626e89bc839e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8125-39 | 00615812539 | 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39) | 2019-06-06 | 0000-00-00 | No | No | Current |