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United States · US · US:31722-871_80bd7b21-6679-4dbb-84dd-f755c7a90166

Buprenorphine HCl

Orange BookUNIISPLATC N07BC01

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN07BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3172287130
    30 TABLET in 1 BOTTLE (31722-871-30)

Annotations

UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A219401
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": "31722-871_80bd7b21-6679-4dbb-84dd-f755c7a90166",
  "productndc": "31722-871",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219401",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Dec 18, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Dec 18, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE",
  "proprietary_name": "Buprenorphine HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219401",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine HCl",
  "start_marketing_date": "20260112",
  "active_numerator_strength": "8"
}

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