Product NDC: | 10544-385 |
Proprietary Name: | ENDOCET |
Non Proprietary Name: | Oxycodone and Acetaminophen |
Active Ingredient(s): | 650; 10 mg/1; mg/1 & nbsp; Oxycodone and Acetaminophen |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 10544-385 |
Labeler Name: | Blenheim Pharmacal, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040341 |
Marketing Category: | ANDA |
Start Marketing Date: | 20080528 |
Package NDC: | 10544-385-30 |
Package Description: | 30 TABLET in 1 BOTTLE (10544-385-30) |
NDC Code | 10544-385-30 |
Proprietary Name | ENDOCET |
Package Description | 30 TABLET in 1 BOTTLE (10544-385-30) |
Product NDC | 10544-385 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Oxycodone and Acetaminophen |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20080528 |
Marketing Category Name | ANDA |
Labeler Name | Blenheim Pharmacal, Inc. |
Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
Strength Number | 650; 10 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |