United States· US:70518-3844_3f8b345a-f793-fa43-e063-6394a90adc2e

buprenorphine hydrochloride and naloxone hydrochloride dihydrate

A oripavine derivatives product containing buprenorphine hydrochloride and naloxone hydrochloride dihydrate, registered in United States by REMEDYREPACK INC..

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 hydrochloride and naloxone hydrochloride dihydrate
Manufacturer: REMEDYREPACK INC.
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
7051838440
30 TABLET in 1 BLISTER PACK (70518-3844-0)

Regulatory notes

UNII (FDA substance ID)

56W8MW3EN1

BUPRENORPHINE HYDROCHLORIDE

RxCUI 203841

Orange Book

A203326

ABAB

DailyMed SPL labels

1 version tracked

Same class

Other records under N02AE

Oripavine derivatives, as other registers publish it.

All buprenorphine hydrochloride and naloxone hydrochloride dihydrate 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/e08a6c48-d52a-4c8e-b09f-d68c3d7b9aec
GET /v1/drugs/e08a6c48-d52a-4c8e-b09f-d68c3d7b9aec?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": "70518-3844_3f8b345a-f793-fa43-e063-6394a90adc2e",
  "productndc": "70518-3844",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203326",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 27, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE;EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jun 27, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
  "proprietary_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA203326",
  "marketing_category": "ANDA",
  "nonproprietary_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate",
  "start_marketing_date": "20230829",
  "active_numerator_strength": "8; 2"
}

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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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