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United States · US · US:71335-1378_154fc76d-ff38-473b-aaa5-017237455b85

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 · 10

  • ndc11
    7133513780
    42 TABLET in 1 BOTTLE (71335-1378-0)
  • ndc11
    7133513781
    30 TABLET in 1 BOTTLE (71335-1378-1)
  • ndc11
    7133513782
    60 TABLET in 1 BOTTLE (71335-1378-2)
  • ndc11
    7133513783
    90 TABLET in 1 BOTTLE (71335-1378-3)
  • ndc11
    7133513784
    120 TABLET in 1 BOTTLE (71335-1378-4)
  • ndc11
    7133513785
    14 TABLET in 1 BOTTLE (71335-1378-5)
  • ndc11
    7133513786
    28 TABLET in 1 BOTTLE (71335-1378-6)
  • ndc11
    7133513787
    6 TABLET in 1 BOTTLE (71335-1378-7)
  • ndc11
    7133513788
    10 TABLET in 1 BOTTLE (71335-1378-8)
  • ndc11
    7133513789
    21 TABLET in 1 BOTTLE (71335-1378-9)

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": "71335-1378_154fc76d-ff38-473b-aaa5-017237455b85",
  "productndc": "71335-1378",
  "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": "8; 2"
}

Related drugs

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