Search by Drug Name or NDC
NDC 70518-1545-01 Carbamazepine 400 mg/1 Details
Carbamazepine 400 mg/1
Carbamazepine is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is CARBAMAZEPINE.
Product Information
| NDC | 70518-1545 |
|---|---|
| Product ID | 70518-1545_030a4311-4bf5-4b69-e063-6394a90ab02e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Carbamazepine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Carbamazepine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | CARBAMAZEPINE |
| Labeler Name | REMEDYREPACK INC. |
| Pharmaceutical Class | 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], Mo |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078115 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70518-1545-01 (70518154501)
| NDC Package Code | 70518-1545-1 |
|---|---|
| Billing NDC | 70518154501 |
| Package | 100 POUCH in 1 BOX (70518-1545-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1545-2) |
| Marketing Start Date | 2022-11-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |