United States · FDA National Drug Code directory
Buprenorphine and Naloxone
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 0378-8766_008d89ec-5bd7-46d9-bc94-9cdc7405f95d
- Product NDC
- 0378-8766
- Form
- FILM
- Composition / generic term
- Buprenorphine and Naloxone
- Labeler
- Mylan Pharmaceuticals Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20200417
- Source listing expiry
- 20271231
Source-listed ingredients
- BUPRENORPHINE HYDROCHLORIDE — 4 mg/1
- NALOXONE HYDROCHLORIDE DIHYDRATE — 1 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 POUCH in 1 CARTON (0378-8766-93) / 1 FILM in 1 POUCH (0378-8766-16) · 0378-8766-93
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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