Product NDC: | 60793-435 |
Proprietary Name: | EMBEDA |
Non Proprietary Name: | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE |
Active Ingredient(s): | 80; 3.2 mg/1; mg/1 & nbsp; MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 60793-435 |
Labeler Name: | King Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022321 |
Marketing Category: | NDA |
Start Marketing Date: | 20090813 |
Package NDC: | 60793-435-01 |
Package Description: | 200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60793-435-01) |
NDC Code | 60793-435-01 |
Proprietary Name | EMBEDA |
Package Description | 200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60793-435-01) |
Product NDC | 60793-435 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20090813 |
Marketing Category Name | NDA |
Labeler Name | King Pharmaceuticals, Inc. |
Substance Name | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE |
Strength Number | 80; 3.2 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |