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Buprenorphine and Naloxone

NDC 0378-8765, Buprenorphine and Naloxone, film, from Mylan Pharmaceuticals Inc..

Product NDC
0378-8765
Status
Listed
Labeler
Mylan Pharmaceuticals Inc.
Dosage form
FILM
Route
BUCCAL, SUBLINGUAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA211785
DEA schedule
CIII
Request
curl https://api.healthcare.dev/v1/drugs/ndc/0378-8765 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • BUPRENORPHINE HYDROCHLORIDE2 mg/1
  • NALOXONE HYDROCHLORIDE DIHYDRATE.5 mg/1

Pharmacologic classes

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

Package NDCNDC-11Package
0378-8765-930037887659330 POUCH in 1 CARTON (0378-8765-93) / 1 FILM in 1 POUCH (0378-8765-16)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/557d8d4d-8751-431c-b18e-9d5cf23fc579
  • NADAC price for package 00378876593

    GET /v1/drugs/nadac/00378876593

Use it

Look up 0378-8765 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/0378-8765 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 0378-8765. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.

Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.