Buprenorphine

Orange BookUNIISPLATC N07BC01

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeN07BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923812042
4 POUCH in 1 CARTON (69238-1204-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

40D3SCR4GZ

BUPRENORPHINE

RxCUI 1819

Orange Book

A211586

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": "69238-1204_5b776a17-f8cd-413d-934b-fcbe0de7f8d4",
  "productndc": "69238-1204",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211586",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MCG/HR",
        "product_no": "001",
        "approval_date": "Apr 14, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MCG/HR",
        "product_no": "002",
        "approval_date": "Apr 14, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MCG/HR",
        "product_no": "003",
        "approval_date": "Apr 14, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MCG/HR",
        "product_no": "004",
        "approval_date": "Apr 14, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MCG/HR",
        "product_no": "005",
        "approval_date": "Apr 14, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE",
  "proprietary_name": "Buprenorphine",
  "active_ingred_unit": "ug/h",
  "application_number": "ANDA211586",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine",
  "start_marketing_date": "20200420",
  "active_numerator_strength": "15"
}

Related drugs

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