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United States · US · US:71335-1296_9edc1edc-dc15-456c-b48f-aebe63540b31

Buprenorphine and Naloxone

Orange BookUNIISPLATC N02AE

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

Identification

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

Packs · 2

  • ndc11
    7133512961
    30 TABLET in 1 BOTTLE (71335-1296-1)
  • ndc11
    7133512962
    10 TABLET in 1 BOTTLE (71335-1296-2)

Annotations

UNII (FDA Substance ID)
40D3SCR4GZ
BUPRENORPHINE
RxCUI 1819
Orange Book
A205022
ABAB
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": "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": "71335-1296_9edc1edc-dc15-456c-b48f-aebe63540b31",
  "productndc": "71335-1296",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205022",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE;EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Sep 19, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE; NALOXONE",
  "proprietary_name": "Buprenorphine and Naloxone",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA205022",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine and Naloxone",
  "start_marketing_date": "20160919",
  "active_numerator_strength": "2; .5"
}

Related drugs

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