Product NDC: | 35356-004 |
Proprietary Name: | Suboxone |
Non Proprietary Name: | buprenorphine hydrochloride, naloxone hydrochloride |
Active Ingredient(s): | 8; 2 mg/1; mg/1 & nbsp; buprenorphine hydrochloride, naloxone hydrochloride |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 35356-004 |
Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020733 |
Marketing Category: | NDA |
Start Marketing Date: | 20111110 |
Package NDC: | 35356-004-30 |
Package Description: | 30 TABLET in 1 BOTTLE, PLASTIC (35356-004-30) |
NDC Code | 35356-004-30 |
Proprietary Name | Suboxone |
Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (35356-004-30) |
Product NDC | 35356-004 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | buprenorphine hydrochloride, naloxone hydrochloride |
Dosage Form Name | TABLET |
Route Name | SUBLINGUAL |
Start Marketing Date | 20111110 |
Marketing Category Name | NDA |
Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
Strength Number | 8; 2 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |