Back to search
🇺🇸

United States · US · US:60687-481_2a815afd-4f27-120b-e063-6394a90a82a0

Buprenorphine

Orange BookUNIISPLATC N07BC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeN07BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068748121
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21) / 1 TABLET in 1 BLISTER PACK (60687-481-11)

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": "60687-481_2a815afd-4f27-120b-e063-6394a90a82a0",
  "productndc": "60687-481",
  "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": "20200206",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N07BC01.

Access this data programmatically

Query Buprenorphine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.