Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate

Orange BookUNIISPLATC N02AE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerClinical Solutions Wholesale, LLC

CountryUS (United States)

ATC codeN02AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5811880208
30 TABLET in 1 BLISTER PACK (58118-8020-8)

Annotations

UNII (FDA Substance ID)

56W8MW3EN1

BUPRENORPHINE HYDROCHLORIDE

RxCUI 203841

Orange Book

A207000

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "58118-8020_0e89609b-bd43-291f-e063-6294a90a623e",
  "productndc": "58118-8020",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207000",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 13, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE;EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Dec 13, 2017"
      }
    ],
    "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": "ANDA207000",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate",
  "start_marketing_date": "20171213",
  "active_numerator_strength": "8; 2"
}

Related drugs

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