United States · FDA National Drug Code directory
Buprenorphine HCl and Naloxone HCl
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
- 65162-415_4cea862f-8edf-4035-a7f5-328beff51a29
- Product NDC
- 65162-415
- Form
- TABLET
- Composition / generic term
- Buprenorphine and Naloxone
- Labeler
- Amneal Pharmaceuticals LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20130222
- Source listing expiry
- 20271231
Source-listed ingredients
- BUPRENORPHINE HYDROCHLORIDE — 8 mg/1
- NALOXONE HYDROCHLORIDE DIHYDRATE — 2 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 TABLET in 1 BOTTLE (65162-415-03) · 65162-415-03
- 90 TABLET in 1 BOTTLE (65162-415-09) · 65162-415-09
Source and coverage
Open FDA National Drug Code directory →
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.
Browse United States records →