CARBAMAZEPINE
- Product NDC
- 13668-268
- 11-digit product format
- 136680268
- Labeler code
- 13668
- Product ID
- 13668-268_2b305f64-7c1a-4cf6-a4ad-57326eb4c874
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA077272
- Marketing category
- ANDA
- Marketing start
- 2009-10-23
- 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 | 308973, 308979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-268-01 | CARBAMAZEPINE | 100 in 1 BOTTLE | TABLET | 100 | | 22 |
| 13668-268-05 | CARBAMAZEPINE | 500 in 1 BOTTLE | TABLET | 500 | | 22 |
| 13668-268-10 | CARBAMAZEPINE | 1000 in 1 BOTTLE | TABLET | 1000 | | 22 |
| 13668-268-30 | CARBAMAZEPINE | 30 in 1 BOTTLE | TABLET | 30 | | 22 |
| 13668-268-31 | CARBAMAZEPINE | 2500 in 1 BOTTLE | TABLET | 2500 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] | 12 | |
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-268 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED] | 21 | Current NDC, Legacy NDC, 5 package rows | 20250223_97e6e175-75e8-437b-b457-ddb1ae4e857d.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 |
|---|
| 13668-268-01 | 13668026801 | 100 TABLET in 1 BOTTLE (13668-268-01) | 100 tablet | 2009-10-23 | 0000-00-00 | No | No | Current |
| 13668-268-05 | 13668026805 | 500 TABLET in 1 BOTTLE (13668-268-05) | 500 tablet | 2009-10-23 | 0000-00-00 | No | No | Current |
| 13668-268-10 | 13668026810 | 1000 TABLET in 1 BOTTLE (13668-268-10) | 1000 tablet | 2009-10-23 | 0000-00-00 | No | No | Current |
| 13668-268-30 | 13668026830 | 30 TABLET in 1 BOTTLE (13668-268-30) | 30 tablet | 2009-10-23 | 0000-00-00 | No | No | Current |
| 13668-268-31 | 13668026831 | 2500 TABLET in 1 BOTTLE (13668-268-31) | 2500 tablet | 2009-10-23 | 0000-00-00 | No | No | Current |