Product NDC: | 43386-350 |
Proprietary Name: | Hydrocodone Bitartrate and Homatropine Methylbromide |
Non Proprietary Name: | Hydrocodone Bitartrate and Homatropine Methylbromide |
Active Ingredient(s): | 1.5; 5 mg/1; mg/1 & nbsp; Hydrocodone Bitartrate and Homatropine Methylbromide |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 43386-350 |
Labeler Name: | GAVIS Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091528 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110216 |
Package NDC: | 43386-350-05 |
Package Description: | 500 TABLET in 1 BOTTLE (43386-350-05) |
NDC Code | 43386-350-05 |
Proprietary Name | Hydrocodone Bitartrate and Homatropine Methylbromide |
Package Description | 500 TABLET in 1 BOTTLE (43386-350-05) |
Product NDC | 43386-350 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydrocodone Bitartrate and Homatropine Methylbromide |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20110216 |
Marketing Category Name | ANDA |
Labeler Name | GAVIS Pharmaceuticals, LLC |
Substance Name | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
Strength Number | 1.5; 5 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] |