buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydrate

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

Drug Facts

Product Profile

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

buprenorphine hydrochloride 2 mg/1, naloxone hydrochloride dihydrate .5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3862
Product ID 70518-3862_422983e3-7c40-32e6-e063-6294a90ae95d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203326
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-09-15

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 705183862
Hyphenated Format 70518-3862

Supplemental Identifiers

RxCUI
351266
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 hydrochloride and naloxone hydrochloride dihydrate (source: ndc)
Generic Name buprenorphine hydrochloride and naloxone hydrochloride dihydrate (source: ndc)
Application Number ANDA203326 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3862-0)
source: ndc

Packages (1)

70518-3862-0 30 TABLET in 1 BLISTER PACK (70518-3862-0)

Ingredients (2)

buprenorphine hydrochloride (2 mg/1) naloxone hydrochloride dihydrate (.5 mg/1)

Linked Drug Pages (1)

buprenorphine hydrochloride and naloxone hydrochloride dihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "422983e3-7c40-32e6-e063-6294a90ae95d", "openfda": {"unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351266"], "spl_set_id": ["43027750-d218-49e5-867f-c941736d2056"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3862-0)", "package_ndc": "70518-3862-0", "marketing_start_date": "20230915"}], "brand_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "product_id": "70518-3862_422983e3-7c40-32e6-e063-6294a90ae95d", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "70518-3862", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA203326", "marketing_category": "ANDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}