Product NDC: | 16590-616 |
Proprietary Name: | OXYCONTIN |
Non Proprietary Name: | OXYCODONE HYDROCHLORIDE |
Active Ingredient(s): | 20 mg/1 & nbsp; OXYCODONE HYDROCHLORIDE |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-616 |
Labeler Name: | STAT Rx USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022272 |
Marketing Category: | NDA |
Start Marketing Date: | 20100808 |
Package NDC: | 16590-616-72 |
Package Description: | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-616-72) |
NDC Code | 16590-616-72 |
Proprietary Name | OXYCONTIN |
Package Description | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-616-72) |
Product NDC | 16590-616 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | OXYCODONE HYDROCHLORIDE |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20100808 |
Marketing Category Name | NDA |
Labeler Name | STAT Rx USA LLC |
Substance Name | OXYCODONE HYDROCHLORIDE |
Strength Number | 20 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |