NDCFind

Buprenorphine And Naloxone 00378-8767

Product NDC

00378-8767
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 Hydrochloride8 mg/1
Naloxone Hydrochloride Dihydrate2 mg/1

Drug Class

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

Packaging Options(1)

30 POUCH in 1 CARTON (0378-8767-93) / 1 FILM in 1 POUCH (0378-8767-16)