CARBAMAZEPINE
- Product NDC
- 46708-731
- 11-digit product format
- 467080731
- Labeler code
- 46708
- Product ID
- 46708-731_a742c03d-10b1-48e2-8df1-48967395ae06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216623
- Marketing category
- ANDA
- Marketing start
- 2024-12-31
- 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 |
|---|
| 46708-731-10 | CARBAMAZEPINE | 100 in 1 CARTON | TABLET | 100 | | 1 |
| 46708-731-10 | CARBAMAZEPINE | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
| 46708-731-31 | CARBAMAZEPINE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 46708-731-60 | CARBAMAZEPINE | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 46708-731-91 | CARBAMAZEPINE | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-731 | CARBAMAZEPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 5 package rows | 20250427_a742c03d-10b1-48e2-8df1-48967395ae06.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-731-10 | 46708073110 | 100 BLISTER PACK in 1 CARTON (46708-731-10) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2025-04-22 | No | No | Current |
| 46708-731-31 | 46708073131 | 100 TABLET in 1 BOTTLE (46708-731-31) | 100 tablet | 2025-04-22 | No | No | Current |
| 46708-731-60 | 46708073160 | 60 TABLET in 1 BOTTLE (46708-731-60) | 60 tablet | 2025-04-22 | No | No | Current |
| 46708-731-91 | 46708073191 | 1000 TABLET in 1 BOTTLE (46708-731-91) | 1000 tablet | 2025-04-22 | No | No | Current |