buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Labeler: major pharmaceuticals
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 major pharmaceuticals
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7009
Product ID 0904-7009_4c41f56b-78b1-4256-b9fc-f7b9b8961fe5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203326
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2014-06-27

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 09047009
Hyphenated Format 0904-7009

Supplemental Identifiers

RxCUI
351266 351267
UNII
5Q187997EE 56W8MW3EN1

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
  • 50 BLISTER PACK in 1 CARTON (0904-7009-06) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7009-06 50 BLISTER PACK in 1 CARTON (0904-7009-06) / 1 TABLET in 1 BLISTER PACK

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": "4c41f56b-78b1-4256-b9fc-f7b9b8961fe5", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["c5fbec69-e7de-44a8-b9fa-0378ae61a9fe"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7009-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7009-06", "marketing_start_date": "20140627"}], "brand_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "product_id": "0904-7009_4c41f56b-78b1-4256-b9fc-f7b9b8961fe5", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0904-7009", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "labeler_name": "Major Pharmaceuticals", "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": "20140627", "listing_expiration_date": "20271231"}