buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Labeler: asclemed usa, 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 asclemed usa, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-534
Product ID 76420-534_f33905ee-0218-1314-e053-2a95a90a25c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209069
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2021-01-22

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 76420534
Hyphenated Format 76420-534

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 hydrochloride and naloxone hydrochloride dihydrate (source: ndc)
Generic Name buprenorphine hydrochloride and naloxone hydrochloride dihydrate (source: ndc)
Application Number ANDA209069 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30)
source: ndc

Packages (1)

76420-534-30 30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride dihydrate (2 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": "f33905ee-0218-1314-e053-2a95a90a25c7", "openfda": {"unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351267"], "spl_set_id": ["597cbc69-84b1-4255-bed9-53d0c6dc2134"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30)", "package_ndc": "76420-534-30", "marketing_start_date": "20230127"}], "brand_name": "BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE", "product_id": "76420-534_f33905ee-0218-1314-e053-2a95a90a25c7", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "76420-534", "dea_schedule": "CIII", "generic_name": "BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA209069", "marketing_category": "ANDA", "marketing_start_date": "20210122", "listing_expiration_date": "20261231"}