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
71335-1378_8c128665-a43f-41ae-a67e-068f840618f5
Product NDC
71335-1378
Form
TABLET
Composition / generic term
Buprenorphine and Naloxone
Labeler
Bryant Ranch Prepack
Marketing category
ANDA
Marketing start / end (source format)
20160919
Source listing expiry
20271231

Source-listed ingredients

  • BUPRENORPHINE — 8 mg/1
  • NALOXONE — 2 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 42 TABLET in 1 BOTTLE (71335-1378-0) · 71335-1378-0
  • 30 TABLET in 1 BOTTLE (71335-1378-1) · 71335-1378-1
  • 60 TABLET in 1 BOTTLE (71335-1378-2) · 71335-1378-2
  • 90 TABLET in 1 BOTTLE (71335-1378-3) · 71335-1378-3
  • 120 TABLET in 1 BOTTLE (71335-1378-4) · 71335-1378-4
  • 14 TABLET in 1 BOTTLE (71335-1378-5) · 71335-1378-5
  • 28 TABLET in 1 BOTTLE (71335-1378-6) · 71335-1378-6
  • 6 TABLET in 1 BOTTLE (71335-1378-7) · 71335-1378-7
  • 10 TABLET in 1 BOTTLE (71335-1378-8) · 71335-1378-8
  • 21 TABLET in 1 BOTTLE (71335-1378-9) · 71335-1378-9

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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