Buprenorphine

Orange BookUNIISPLATC N07BC01

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeN07BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093323940
4 POUCH in 1 CARTON (0093-3239-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

40D3SCR4GZ

BUPRENORPHINE

RxCUI 1819

Orange Book

A204937

ABABABABAB

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": "0093-3239_192dd133-b93c-43a0-80be-550b6e771c4f",
  "productndc": "0093-3239",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204937",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MCG/HR",
        "product_no": "001",
        "approval_date": "Nov 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MCG/HR",
        "product_no": "002",
        "approval_date": "Nov 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MCG/HR",
        "product_no": "003",
        "approval_date": "Nov 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MCG/HR",
        "product_no": "004",
        "approval_date": "Nov 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MCG/HR",
        "product_no": "005",
        "approval_date": "Jun 29, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE",
  "proprietary_name": "Buprenorphine",
  "active_ingred_unit": "ug/h",
  "application_number": "ANDA204937",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine",
  "start_marketing_date": "20211227",
  "active_numerator_strength": "7.5"
}

Related drugs

Other records sharing ATC code N07BC01.

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