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] |