| Product NDC: | 50383-043 |
| Proprietary Name: | Hydrocodone Bitartrate and Homatropine Methylbromide |
| Non Proprietary Name: | Hydrocodone Bitartrate and Homatropine Methylbromide |
| Active Ingredient(s): | 1.5; 5 mg/5mL; mg/5mL & nbsp; Hydrocodone Bitartrate and Homatropine Methylbromide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SYRUP |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50383-043 |
| Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040613 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080208 |
| Package NDC: | 50383-043-16 |
| Package Description: | 473 mL in 1 BOTTLE (50383-043-16) |
| NDC Code | 50383-043-16 |
| Proprietary Name | Hydrocodone Bitartrate and Homatropine Methylbromide |
| Package Description | 473 mL in 1 BOTTLE (50383-043-16) |
| Product NDC | 50383-043 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydrocodone Bitartrate and Homatropine Methylbromide |
| Dosage Form Name | SYRUP |
| Route Name | ORAL |
| Start Marketing Date | 20080208 |
| Marketing Category Name | ANDA |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
| Strength Number | 1.5; 5 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |