BELBUCA

Orange BookUNIISPLATC N07BC01

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

Identification

ManufacturerBioDelivery Sciences International Inc

CountryUS (United States)

ATC codeN07BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5938502160
60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01)

Annotations

UNII (FDA Substance ID)

56W8MW3EN1

BUPRENORPHINE HYDROCHLORIDE

RxCUI 203841

Orange Book

N207932

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": "BUCCAL",
  "spl_meta": {
    "bc2b7a3d-72cf-497c-95b0-ba2b71f63c64": {
      "match": "brand_token",
      "title": "BELBUCA (BUPRENORPHINE HYDROCHLORIDE) FILM, SOLUBLE [BIODELIVERY SCIENCES INTERNATIONAL INC]",
      "spl_version": "18",
      "published_date": "2026-01-06"
    }
  },
  "productid": "59385-021_16403e7a-5881-43d2-990c-a7d673971c3d",
  "productndc": "59385-021",
  "dosage_form": "FILM, SOLUBLE",
  "orange_book": {
    "appl_no": "207932",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.075MG BASE",
        "product_no": "001",
        "approval_date": "Oct 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.15MG BASE",
        "product_no": "002",
        "approval_date": "Oct 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.3MG BASE",
        "product_no": "003",
        "approval_date": "Oct 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.45MG BASE",
        "product_no": "004",
        "approval_date": "Oct 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.6MG BASE",
        "product_no": "005",
        "approval_date": "Oct 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.75MG BASE",
        "product_no": "006",
        "approval_date": "Oct 23, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.9MG BASE",
        "product_no": "007",
        "approval_date": "Oct 23, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE",
  "proprietary_name": "BELBUCA",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA207932",
  "marketing_category": "NDA",
  "nonproprietary_name": "buprenorphine hydrochloride",
  "start_marketing_date": "20170901",
  "active_numerator_strength": "75"
}

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