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United States · US · US:67296-2063_4b54bad7-9105-51e9-e063-6294a90a8d8c

Buprenorphine and Naloxone

Orange BookUNIISPLATC N02AE

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

Identification

ManufacturerRedpharm Drug
CountryUS (United States)
ATC codeN02AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6729620633
    30 POUCH in 1 CARTON (67296-2063-3) / 1 FILM in 1 POUCH
  • ndc11
    6729620636
    6 POUCH in 1 CARTON (67296-2063-6) / 1 FILM in 1 POUCH

Annotations

UNII (FDA Substance ID)
56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE
RxCUI 203841
Orange Book
A211785
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": "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": "67296-2063_4b54bad7-9105-51e9-e063-6294a90a8d8c",
  "productndc": "67296-2063",
  "dosage_form": "FILM",
  "orange_book": {
    "appl_no": "211785",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE;EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Apr 17, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
  "proprietary_name": "Buprenorphine and Naloxone",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211785",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine and Naloxone",
  "start_marketing_date": "20200417",
  "active_numerator_strength": "2; .5"
}

Related drugs

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