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United States · US · US:50742-365_4db0df39-ce1f-bb08-e063-6294a90a3a4a

Buprenorphine and Naloxone

Orange BookUNIISPLATC N02AE

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

Identification

ManufacturerINGENUS PHARMACEUTICALS, LLC
CountryUS (United States)
ATC codeN02AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5074236530
    30 POUCH in 1 CARTON (50742-365-30) / 1 FILM in 1 POUCH (50742-365-01)

Annotations

UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A212756
ABABABAB
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; 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": "50742-365_4db0df39-ce1f-bb08-e063-6294a90a3a4a",
  "productndc": "50742-365",
  "dosage_form": "FILM",
  "orange_book": {
    "appl_no": "212756",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE;EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jun 2, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12MG BASE;EQ 3MG BASE",
        "product_no": "002",
        "approval_date": "Jun 2, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "003",
        "approval_date": "Feb 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE;EQ 1MG BASE",
        "product_no": "004",
        "approval_date": "Feb 13, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
  "proprietary_name": "Buprenorphine and Naloxone",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA212756",
  "marketing_category": "ANDA",
  "nonproprietary_name": "buprenorphine and naloxone",
  "start_marketing_date": "20230829",
  "active_numerator_strength": "12; 3"
}

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