Carbamazepine is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Precision Dose, Inc.. The primary component is Carbamazepine.
| Product ID | 68094-007_279d3e28-03c4-451d-895b-5ebb4fb4b8d7 |
| NDC | 68094-007 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Carbamazepine |
| Generic Name | Carbamazepine |
| Dosage Form | Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-10-04 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075714 |
| Labeler Name | Precision Dose, Inc. |
| Substance Name | CARBAMAZEPINE |
| Active Ingredient Strength | 100 mg/5mL |
| Pharm Classes | Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2017-10-04 |
| Marketing End Date | 2023-08-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075714 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-10-04 |
| Marketing Category | ANDA |
| Application Number | ANDA075714 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-10-04 |
| Ingredient | Strength |
|---|---|
| CARBAMAZEPINE | 100 mg/5mL |
| SPL SET ID: | b0655a23-fea0-4a8c-aec2-e0e636528eb1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-0109 | Carbamazepine | Carbamazepine |
| 0093-0778 | Carbamazepine | Carbamazepine |
| 68071-3282 | Carbamazepine | Carbamazepine |
| 68071-4313 | CARBAMAZEPINE | CARBAMAZEPINE |
| 68084-444 | Carbamazepine | Carbamazepine |
| 68094-007 | Carbamazepine | Carbamazepine |
| 68094-008 | Carbamazepine | Carbamazepine |
| 68382-555 | carbamazepine | carbamazepine |
| 68382-556 | carbamazepine | carbamazepine |
| 68382-557 | carbamazepine | carbamazepine |
| 68788-7210 | CARBAMAZEPINE | CARBAMAZEPINE |
| 68788-9492 | CARBAMAZEPINE | CARBAMAZEPINE |
| 68788-9812 | Carbamazepine | Carbamazepine |
| 69189-0410 | Carbamazepine | Carbamazepine |
| 70518-0181 | Carbamazepine | Carbamazepine |
| 70518-0124 | Carbamazepine | Carbamazepine |
| 70518-0902 | CARBAMAZEPINE | CARBAMAZEPINE |
| 70518-1769 | Carbamazepine | Carbamazepine |
| 70518-1436 | Carbamazepine | Carbamazepine |
| 70518-1545 | Carbamazepine | Carbamazepine |
| 70518-1433 | Carbamazepine | Carbamazepine |
| 70771-1470 | carbamazepine | carbamazepine |
| 70771-1469 | carbamazepine | carbamazepine |
| 70771-1468 | carbamazepine | carbamazepine |
| 71205-025 | CARBAMAZEPINE | CARBAMAZEPINE |
| 71335-0461 | Carbamazepine | Carbamazepine |
| 71335-0462 | CARBAMAZEPINE | CARBAMAZEPINE |
| 0615-3505 | Carbamazepine | Carbamazepine |
| 71335-0691 | CARBAMAZEPINE | CARBAMAZEPINE |
| 0615-4515 | CARBAMAZEPINE | CARBAMAZEPINE |
| 0904-3854 | CARBAMAZEPINE | CARBAMAZEPINE |
| 0904-6172 | CARBAMAZEPINE | CARBAMAZEPINE |
| 13668-271 | CARBAMAZEPINE | CARBAMAZEPINE |
| 13668-268 | CARBAMAZEPINE | CARBAMAZEPINE |
| 17856-4047 | Carbamazepine | Carbamazepine |
| 21695-724 | Carbamazepine | Carbamazepine |
| 29033-004 | Carbamazepine | Carbamazepine |
| 33261-676 | Carbamazepine | Carbamazepine |
| 43063-328 | Carbamazepine | Carbamazepine |
| 43353-953 | CARBAMAZEPINE | CARBAMAZEPINE |
| 49999-616 | CARBAMAZEPINE | CARBAMAZEPINE |
| 50090-2161 | CARBAMAZEPINE | CARBAMAZEPINE |
| 51079-385 | Carbamazepine | Carbamazepine |
| 51079-870 | Carbamazepine | Carbamazepine |
| 51655-017 | CARBAMAZEPINE | CARBAMAZEPINE |
| 51672-4047 | Carbamazepine | Carbamazepine |
| 51672-4151 | Carbamazepine | Carbamazepine |
| 51672-4124 | Carbamazepine | Carbamazepine |
| 51672-4125 | Carbamazepine | Carbamazepine |
| 51672-4149 | Carbamazepine | Carbamazepine |