buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1, naloxone hydrochloride dihydrate 2 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3389
Product ID 70518-3389_3a8564e8-d5ec-d4cb-e063-6394a90ad524
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205601
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-03-16

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa] partial opioid agonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183389
Hyphenated Format 70518-3389

Supplemental Identifiers

RxCUI
351267
UNII
56W8MW3EN1 5Q187997EE

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name buprenorphine and naloxone (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA205601 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3389-0)
source: ndc

Packages (1)

70518-3389-0 30 TABLET in 1 BLISTER PACK (70518-3389-0)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride dihydrate (2 mg/1)

Linked Drug Pages (1)

Buprenorphine and Naloxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "3a8564e8-d5ec-d4cb-e063-6394a90ad524", "openfda": {"unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351267"], "spl_set_id": ["072b2c2e-a564-4bb4-8954-9349a7923807"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3389-0)", "package_ndc": "70518-3389-0", "marketing_start_date": "20220316"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "70518-3389_3a8564e8-d5ec-d4cb-e063-6394a90ad524", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "70518-3389", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA205601", "marketing_category": "ANDA", "marketing_start_date": "20220316", "listing_expiration_date": "20261231"}