carbamazepine
- Product NDC
- 68382-555
- 11-digit product format
- 683820555
- Labeler code
- 68382
- Product ID
- 68382-555_cb38c07d-4352-4049-a720-503cfc5db524
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carbamazepine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA205571
- Marketing category
- ANDA
- Marketing start
- 2019-03-12
- 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 | 199378, 402505, 402506 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-555-01 | carbamazepine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 7 |
| 68382-555-06 | carbamazepine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 7 |
| 68382-555-16 | carbamazepine | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 7 |
| 68382-555-30 | carbamazepine | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 7 |
| 68382-555-30 | carbamazepine | 10 in 1 CARTON | TABLET, EXTENDED RELEASE | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-555 | CARBAMAZEPINE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240404_c5e4a25a-0137-4327-96f5-15735891ad5c.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 |
|---|
| 68382-555-01 | 68382055501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-555-01) | | 2019-03-12 | 0000-00-00 | No | No | Current |
| 68382-555-06 | 68382055506 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-555-06) | | 2019-03-12 | 0000-00-00 | No | No | Current |
| 68382-555-16 | 68382055516 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-555-16) | | 2019-03-12 | 0000-00-00 | No | No | Current |
| 68382-555-30 | 68382055530 | 10 BLISTER PACK in 1 CARTON (68382-555-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2019-03-12 | 0000-00-00 | No | No | Current |