United States· US:71335-1296_9edc1edc-dc15-456c-b48f-aebe63540b31

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 · 2

ndc11
7133512961
30 TABLET in 1 BOTTLE (71335-1296-1)
ndc11
7133512962
10 TABLET in 1 BOTTLE (71335-1296-2)

Regulatory notes

UNII (FDA substance ID)

40D3SCR4GZ

BUPRENORPHINE

RxCUI 1819

Orange Book

A205022

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/de1ddb3e-c269-4024-a416-fd5c179fa67a
GET /v1/drugs/de1ddb3e-c269-4024-a416-fd5c179fa67a?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": "40D3SCR4GZ",
    "rxcui": "1819",
    "inchikey": "RMRJXGBAOAMLHD-IHFGGWKQSA-N",
    "display_name": "BUPRENORPHINE",
    "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": "71335-1296_9edc1edc-dc15-456c-b48f-aebe63540b31",
  "productndc": "71335-1296",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205022",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE;EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Sep 19, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE; NALOXONE",
  "proprietary_name": "Buprenorphine and Naloxone",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA205022",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine and Naloxone",
  "start_marketing_date": "20160919",
  "active_numerator_strength": "2; .5"
}

API reference MCP server Plans

See everything about buprenorphine and naloxone.

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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