Product NDC: | 35356-661 |
Proprietary Name: | Tramadol Hydrochloride and Acetaminophen |
Non Proprietary Name: | tramadol hydrochloride and acetaminophen |
Active Ingredient(s): | 325; 37.5 mg/1; mg/1 & nbsp; tramadol hydrochloride and acetaminophen |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 35356-661 |
Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021123 |
Marketing Category: | NDA |
Start Marketing Date: | 20010815 |
Package NDC: | 35356-661-90 |
Package Description: | 90 TABLET, COATED in 1 BOTTLE (35356-661-90) |
NDC Code | 35356-661-90 |
Proprietary Name | Tramadol Hydrochloride and Acetaminophen |
Package Description | 90 TABLET, COATED in 1 BOTTLE (35356-661-90) |
Product NDC | 35356-661 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | tramadol hydrochloride and acetaminophen |
Dosage Form Name | TABLET, COATED |
Route Name | ORAL |
Start Marketing Date | 20010815 |
Marketing Category Name | NDA |
Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Substance Name | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
Strength Number | 325; 37.5 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |