buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler redpharm drug
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2164
Product ID 67296-2164_45abede5-7ceb-60e1-e063-6394a90a9a4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205601
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2020-04-13

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 672962164
Hyphenated Format 67296-2164

Supplemental Identifiers

RxCUI
351267
UPC
0342858602037 0342858601030
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
  • 12 TABLET in 1 BOTTLE, PLASTIC (67296-2164-1)
  • 6 TABLET in 1 BOTTLE, PLASTIC (67296-2164-6)
source: ndc

Packages (2)

67296-2164-1 12 TABLET in 1 BOTTLE, PLASTIC (67296-2164-1) 67296-2164-6 6 TABLET in 1 BOTTLE, PLASTIC (67296-2164-6)

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": "45abede5-7ceb-60e1-e063-6394a90a9a4a", "openfda": {"upc": ["0342858602037", "0342858601030"], "unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351267"], "spl_set_id": ["374530e2-3b2e-77d7-e063-6394a90a37c9"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE, PLASTIC (67296-2164-1)", "package_ndc": "67296-2164-1", "marketing_start_date": "20200413"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (67296-2164-6)", "package_ndc": "67296-2164-6", "marketing_start_date": "20200413"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "67296-2164_45abede5-7ceb-60e1-e063-6394a90a9a4a", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "67296-2164", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Redpharm Drug", "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": "20200413", "listing_expiration_date": "20261231"}