CARBAMAZEPINE
- Product NDC
- 60505-0183
- 11-digit product format
- 605050183
- Labeler code
- 60505
- Product ID
- 60505-0183_e6a60bd5-3bd4-783c-7fb0-25fee964d387
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA075948
- Marketing category
- ANDA
- Marketing start
- 2002-09-01
- 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 |
|---|
| 60505-0183-0 | CARBAMAZEPINE | 100 in 1 BOTTLE | TABLET | 100 | | 20 |
| 60505-0183-1 | CARBAMAZEPINE | 1000 in 1 BOTTLE | TABLET | 1000 | | 20 |
| 60505-0183-5 | CARBAMAZEPINE | 500 in 1 BOTTLE | TABLET | 500 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0183 | CARBAMAZEPINE TABLET [APOTEX CORP.] | 18 | Current NDC, Legacy NDC, 3 package rows | 20240206_bf0d012f-da14-8ce3-d74f-56172cddebc5.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 |
|---|
| 60505-0183-0 | 60505018300 | 100 TABLET in 1 BOTTLE (60505-0183-0) | 100 tablet | 2002-09-01 | 0000-00-00 | No | No | Current |
| 60505-0183-1 | 60505018301 | 1000 TABLET in 1 BOTTLE (60505-0183-1) | 1000 tablet | 2002-09-01 | 0000-00-00 | No | No | Current |
| 60505-0183-5 | 60505018305 | 500 TABLET in 1 BOTTLE (60505-0183-5) | 500 tablet | 2002-09-01 | 2023-01-21 | No | No | Current |