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NDC 35561-0357-12 CARBAMAZEPINE ER 400 mg/1 Details
CARBAMAZEPINE ER 400 mg/1
CARBAMAZEPINE ER is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AustarPharma LLC. The primary component is CARBAMAZEPINE.
MedlinePlus Drug Summary
Carbamazepine is used alone or in combination with other medications to control certain types of seizures in people with epilepsy. It is also used to treat trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine extended-release capsules (Equetro brand only) are also used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen at the same time) in patients with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Carbamazepine is in a class of medications called anticonvulsants. It works by reducing abnormal electrical activity in the brain.
Related Packages: 35561-0357-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Carbamazepine
Product Information
| NDC | 35561-0357 |
|---|---|
| Product ID | 35561-357_0e052da8-dac8-3d62-e063-6294a90ad7a8 |
| 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 ER |
| 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 | AustarPharma LLC |
| 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 | ANDA215591 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 35561-0357-12 (35561035712)
| NDC Package Code | 35561-357-12 |
|---|---|
| Billing NDC | 35561035712 |
| Package | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-357-12) |
| Marketing Start Date | 2021-12-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |