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Buprenorphine HCl and Naloxone HCl

NDC 65162-416, Buprenorphine and Naloxone, tablet, from Amneal Pharmaceuticals LLC.

Product NDC
65162-416
Status
Listed
Labeler
Amneal Pharmaceuticals LLC
Dosage form
TABLET
Route
SUBLINGUAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
ANDA
Application
ANDA203136
DEA schedule
CIII
Request
curl https://api.healthcare.dev/v1/drugs/ndc/65162-416 \
  -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
65162-416-036516204160330 TABLET in 1 BOTTLE (65162-416-03)
65162-416-096516204160990 TABLET in 1 BOTTLE (65162-416-09)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/17b63f10-c9df-44be-80fa-6f1c305583b8

  • NADAC price for package 65162041603

    GET /v1/drugs/nadac/65162041603

Use it

Look up 65162-416 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/65162-416 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 65162-416. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.
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Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.