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United States· US:71335-1378_154fc76d-ff38-473b-aaa5-017237455b85

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBuprenorphine and NaloxoneATCN02AEREGISTER NO.US:71335-1378_154fc76…PACKS LISTED10CHECKEDJune 3, 2026

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 · 10

  • ndc11
    7133513780
    42 TABLET in 1 BOTTLE (71335-1378-0)
  • ndc11
    7133513781
    30 TABLET in 1 BOTTLE (71335-1378-1)
  • ndc11
    7133513782
    60 TABLET in 1 BOTTLE (71335-1378-2)
  • ndc11
    7133513783
    90 TABLET in 1 BOTTLE (71335-1378-3)
  • ndc11
    7133513784
    120 TABLET in 1 BOTTLE (71335-1378-4)
  • ndc11
    7133513785
    14 TABLET in 1 BOTTLE (71335-1378-5)
  • ndc11
    7133513786
    28 TABLET in 1 BOTTLE (71335-1378-6)
  • ndc11
    7133513787
    6 TABLET in 1 BOTTLE (71335-1378-7)
  • ndc11
    7133513788
    10 TABLET in 1 BOTTLE (71335-1378-8)
  • ndc11
    7133513789
    21 TABLET in 1 BOTTLE (71335-1378-9)

Regulatory notes

UNII (FDA substance ID)
40D3SCR4GZ
BUPRENORPHINE
RxCUI 1819
Orange Book
A205022
ABAB
DailyMed SPL labels
1 version tracked

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/02123801-9805-43ae-b73c-dd34deb83ed0
GET /v1/drugs/02123801-9805-43ae-b73c-dd34deb83ed0?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": "71335-1378_154fc76d-ff38-473b-aaa5-017237455b85",
  "productndc": "71335-1378",
  "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": "8; 2"
}

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.