NDC 0378-8768 – Buprenorphine and Naloxone

Buprenorphine Hydrochloride 12 mg/1; Naloxone Hydrochloride Dihydrate 3 mg/1 · Film · Buccal, Sublingual

Human Prescription Drug DEA schedule CIII

Product NDC0378-8768

Product details

Brand name
Buprenorphine and Naloxone
Generic name
Buprenorphine and Naloxone
Labeler
Mylan Pharmaceuticals Inc.
Dosage form
Film
Route
Buccal, Sublingual
Marketing category
ANDA · ANDA207607
Marketed since
February 20, 2019
Listing expires
December 31, 2027
Pharmacologic class
Opioid Antagonist; Partial Opioid Agonist

Active ingredients

Uses, dosage, side effects and warnings for Buprenorphine and Naloxone →

Package NDC codes (1)

Package NDCDescriptionSince
0378-8768-9330 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16)Feb 20, 2019

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