United States· US:72162-1346_b4047649-88f6-4710-9a05-f0daf149b3c1

Buprenorphine and Naloxone

A oripavine derivatives product containing buprenorphine and naloxone, registered in United States by Bryant Ranch Prepack.

ATC N02AEOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Buprenorphine and Naloxone
Manufacturer: Bryant Ranch Prepack
Country: United States (US)
ATC code: N02AE
ATC class: Oripavine derivatives
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 1

ndc11
7216213463
30 TABLET in 1 BOTTLE, PLASTIC (72162-1346-3)

Regulatory notes

UNII (FDA substance ID)

56W8MW3EN1

BUPRENORPHINE HYDROCHLORIDE

RxCUI 203841

Orange Book

A205601

ABAB

DailyMed SPL labels

1 version tracked

Same class

Other records under N02AE

Oripavine derivatives, as other registers publish it.

All buprenorphine and naloxone products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/f4c4e91e-2398-4a8c-82db-940c331b1527
GET /v1/drugs/f4c4e91e-2398-4a8c-82db-940c331b1527?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "56W8MW3EN1",
    "rxcui": "203841",
    "inchikey": "UAIXRPCCYXNJMQ-RZIPZOSSSA-N",
    "display_name": "BUPRENORPHINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBLINGUAL",
  "spl_meta": {
    "2738feae-316e-426f-971c-5f142ac01b60": {
      "match": "brand_token",
      "title": "BUPRENORPHINE PATCH [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "17",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72162-1346_b4047649-88f6-4710-9a05-f0daf149b3c1",
  "productndc": "72162-1346",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205601",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE;EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Mar 30, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
  "proprietary_name": "Buprenorphine and Naloxone",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA205601",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine and Naloxone",
  "start_marketing_date": "20200413",
  "active_numerator_strength": "2; .5"
}

API reference MCP server Plans

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This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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