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.
| Product ID | 35561-355_dc84da79-1dec-755b-e053-2a95a90a973b |
| NDC | 35561-355 |
| Product Type | Human Prescription Drug |
| Proprietary Name | CARBAMAZEPINE ER |
| Generic Name | Carbamazepine |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-12-09 |
| Marketing Category | ANDA / |
| Application Number | ANDA215591 |
| Labeler Name | AustarPharma LLC |
| Substance Name | CARBAMAZEPINE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm 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 | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2021-12-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68084-562 | Carbamazepine ER | Carbamazepine ER |
| 68084-561 | Carbamazepine ER | Carbamazepine ER |
| 0781-5988 | Carbamazepine ER | Carbamazepine ER |
| 0781-5987 | Carbamazepine ER | Carbamazepine ER |
| 0781-8016 | Carbamazepine ER | Carbamazepine ER |
| 70518-2653 | Carbamazepine ER | Carbamazepine ER |
| 0093-0109 | Carbamazepine | Carbamazepine |
| 0093-0778 | Carbamazepine | Carbamazepine |
| 0093-0090 | Epitol | Carbamazepine |
| 0078-0508 | Tegretol | carbamazepine |
| 0078-0509 | Tegretol | carbamazepine |
| 0078-0510 | Tegretol | carbamazepine |
| 0078-0511 | Tegretol | carbamazepine |
| 0078-0512 | Tegretol | carbamazepine |