BUPRENORPHINE

Orange BookUNIISPLATC N07BC01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN07BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133509501
60 TABLET in 1 BOTTLE (71335-0950-1)
ndc11
7133509502
90 TABLET in 1 BOTTLE (71335-0950-2)
ndc11
7133509503
30 TABLET in 1 BOTTLE (71335-0950-3)
ndc11
7133509504
7 TABLET in 1 BOTTLE (71335-0950-4)
ndc11
7133509505
28 TABLET in 1 BOTTLE (71335-0950-5)
ndc11
7133509506
1 TABLET in 1 BOTTLE (71335-0950-6)
ndc11
7133509507
12 TABLET in 1 BOTTLE (71335-0950-7)
ndc11
7133509508
120 TABLET in 1 BOTTLE (71335-0950-8)

Annotations

UNII (FDA Substance ID)

56W8MW3EN1

BUPRENORPHINE HYDROCHLORIDE

RxCUI 203841

Orange Book

A207276

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": "71335-0950_942860b1-ae08-462f-927a-d611ad05dc40",
  "productndc": "71335-0950",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207276",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Mar 27, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Mar 27, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE",
  "proprietary_name": "BUPRENORPHINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207276",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BUPRENORPHINE",
  "start_marketing_date": "20171025",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N07BC01.

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