Product NDC: | 76014-001 |
Proprietary Name: | Hycet |
Non Proprietary Name: | hydrocodone bitartrate and acetaminophen |
Active Ingredient(s): | 325; 7.5 mg/15mL; mg/15mL & nbsp; hydrocodone bitartrate and acetaminophen |
Administration Route(s): | ORAL |
Dosage Form(s): | SYRUP |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 76014-001 |
Labeler Name: | Eclat Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040482 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110801 |
Package NDC: | 76014-001-22 |
Package Description: | 30 mL in 1 BOTTLE, PLASTIC (76014-001-22) |
NDC Code | 76014-001-22 |
Proprietary Name | Hycet |
Package Description | 30 mL in 1 BOTTLE, PLASTIC (76014-001-22) |
Product NDC | 76014-001 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | hydrocodone bitartrate and acetaminophen |
Dosage Form Name | SYRUP |
Route Name | ORAL |
Start Marketing Date | 20110801 |
Marketing Category Name | ANDA |
Labeler Name | Eclat Pharmaceuticals, LLC |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength Number | 325; 7.5 |
Strength Unit | mg/15mL; mg/15mL |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |