buprenorphine and naloxone (42858-602)

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone

Generic Name buprenorphine and naloxone

Labeler rhodes pharmaceuticals l.p.

Dosage Form TABLET

Routes

SUBLINGUAL

Active Ingredients

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

Manufacturer

Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-602

Product ID 42858-602_edbbdc14-dfb0-4ff4-87f3-b217d6bc36f7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205601

DEA Schedule ciii

Listing Expiration 2027-12-31

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 42858602

Hyphenated Format 42858-602

Supplemental Identifiers

RxCUI

351266 351267

UPC

0342858602037 0342858601030

UNII

5Q187997EE 56W8MW3EN1

Packaging Origin

Original Packager

true

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 BOTTLE, PLASTIC (42858-602-03)

source: ndc

Packages (1)

42858-602-03 30 TABLET in 1 BOTTLE, PLASTIC (42858-602-03)

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": "edbbdc14-dfb0-4ff4-87f3-b217d6bc36f7", "openfda": {"upc": ["0342858602037", "0342858601030"], "unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["794724a6-0fba-bc8d-ecdb-9e3be8ea2191"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (42858-602-03)", "package_ndc": "42858-602-03", "marketing_start_date": "20200413"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "42858-602_edbbdc14-dfb0-4ff4-87f3-b217d6bc36f7", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "42858-602", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Rhodes Pharmaceuticals L.P.", "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": "20271231"}