Product NDC: | 35356-610 |
Proprietary Name: | EXALGO |
Non Proprietary Name: | Hydromorphone Hydrochloride |
Active Ingredient(s): | 8 mg/1 & nbsp; Hydromorphone Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 35356-610 |
Labeler Name: | Lake Erie Medical DBA Quality Care Products LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021217 |
Marketing Category: | NDA |
Start Marketing Date: | 20110314 |
Package NDC: | 35356-610-30 |
Package Description: | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-610-30) |
NDC Code | 35356-610-30 |
Proprietary Name | EXALGO |
Package Description | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-610-30) |
Product NDC | 35356-610 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydromorphone Hydrochloride |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20110314 |
Marketing Category Name | NDA |
Labeler Name | Lake Erie Medical DBA Quality Care Products LLC |
Substance Name | HYDROMORPHONE HYDROCHLORIDE |
Strength Number | 8 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |