Carbamazepine
- Product NDC
- 70518-3773
- 11-digit product format
- 705183773
- Labeler code
- 70518
- Product ID
- 70518-3773_4f84eb7a-25c9-020f-e063-6394a90a16d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA216594
- Marketing category
- ANDA
- Marketing start
- 2023-06-22
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3773-0 | Carbamazepine | 100 in 1 BOX | TABLET, EXTENDED RELEASE | 100 | | 6 |
| 70518-3773-1 | Carbamazepine | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3773 | CARBAMAZEPINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 4 | Current NDC, 2 package rows | 20250429_3207764f-0663-477e-ad1f-f5fb43b6bbf3.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 |
|---|
| 70518-3773-0 | 70518377300 | 100 POUCH in 1 BOX (70518-3773-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3773-1) | 100 pouch | 2023-06-22 | No | No | Historical |
| 70518-3773-1 | 70518377301 | 1 in 1 POUCH | | | | | Historical |