buprenorphine transdermal system

Orange BookUNIISPLATC N07BC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAlvogen Inc.

CountryUS (United States)

ATC codeN07BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4778140704
4 POUCH in 1 CARTON (47781-407-04) / 1 PATCH in 1 POUCH (47781-407-11) / 168 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

40D3SCR4GZ

BUPRENORPHINE

RxCUI 1819

Orange Book

A207490

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "40D3SCR4GZ",
    "rxcui": "1819",
    "inchikey": "RMRJXGBAOAMLHD-IHFGGWKQSA-N",
    "display_name": "BUPRENORPHINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "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": "47781-407_7f83c8aa-7590-e2fe-4998-55323eadd112",
  "productndc": "47781-407",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207490",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MCG/HR",
        "product_no": "001",
        "approval_date": "May 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MCG/HR",
        "product_no": "002",
        "approval_date": "May 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MCG/HR",
        "product_no": "003",
        "approval_date": "May 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MCG/HR",
        "product_no": "004",
        "approval_date": "May 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7.5MCG/HR",
        "product_no": "005",
        "approval_date": "Mar 21, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE",
  "proprietary_name": "buprenorphine transdermal system",
  "active_ingred_unit": "ug/h",
  "application_number": "ANDA207490",
  "marketing_category": "ANDA",
  "nonproprietary_name": "buprenorphine",
  "start_marketing_date": "20220517",
  "active_numerator_strength": "10"
}

Related drugs

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