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United States · US · US:72888-183_47a1af00-e74e-d1cc-e063-6394a90ab889

buprenorphine hydrochloride

Orange BookUNIISPLATC N07BC01

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

Identification

ManufacturerAdvagen Pharma Ltd
CountryUS (United States)
ATC codeN07BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7288818330
    30 TABLET in 1 BOTTLE (72888-183-30)
  • ndc11
    7288818390
    90 TABLET in 1 BOTTLE (72888-183-90)

Annotations

UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A090279
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": "72888-183_47a1af00-e74e-d1cc-e063-6394a90ab889",
  "productndc": "72888-183",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090279",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jun 10, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Jun 10, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE",
  "proprietary_name": "buprenorphine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090279",
  "marketing_category": "ANDA",
  "nonproprietary_name": "buprenorphine hydrochloride",
  "start_marketing_date": "20150610",
  "active_numerator_strength": "8"
}

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