NDCFind

Buprenorphine And Naloxone 00378-8768-93

Package NDC

00378-8768-93

Product NDC: 00378-8768

Manufacturer
Mylan Pharmaceuticals Inc.
Dosage Form
Film
Route
Buccal And Sublingual
Product Type
Human Prescription Drug
DEA Schedule
Schedule CIII
Marketing Start
February 20, 2019
Listing Expires
December 31, 2027
Application
ANDA207607

Active Ingredients

IngredientStrength
Buprenorphine Hydrochloride12 mg/1
Naloxone Hydrochloride Dihydrate3 mg/1

Drug Class

Opioid Antagonist [EPC]Opioid Antagonists [MoA]Partial Opioid Agonist [EPC]

Selected Package

00378-8768-93Selected

30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16)