| Product NDC: | 68094-214 |
| Proprietary Name: | Carbamazepine |
| Non Proprietary Name: | Carbamazepine |
| Active Ingredient(s): | 200 mg/10mL & nbsp; Carbamazepine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68094-214 |
| Labeler Name: | Precision Dose Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076729 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20030902 |
| Package NDC: | 68094-214-62 |
| Package Description: | 3 TRAY in 1 CASE (68094-214-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (68094-214-59) |
| NDC Code | 68094-214-62 |
| Proprietary Name | Carbamazepine |
| Package Description | 3 TRAY in 1 CASE (68094-214-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (68094-214-59) |
| Product NDC | 68094-214 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Carbamazepine |
| Dosage Form Name | SUSPENSION |
| Route Name | ORAL |
| Start Marketing Date | 20030902 |
| Marketing Category Name | ANDA |
| Labeler Name | Precision Dose Inc. |
| Substance Name | CARBAMAZEPINE |
| Strength Number | 200 |
| Strength Unit | mg/10mL |
| Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] |