buprenorphine hcl and naloxone hcl

Generic: buprenorphine and naloxone

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hcl and naloxone hcl
Generic Name buprenorphine and naloxone
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-415
Product ID 65162-415_4cea862f-8edf-4035-a7f5-328beff51a29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203136
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2013-02-22

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 65162415
Hyphenated Format 65162-415

Supplemental Identifiers

RxCUI
351266 351267
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 hcl and naloxone hcl (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA203136 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-415-03)
  • 90 TABLET in 1 BOTTLE (65162-415-09)
source: ndc

Packages (2)

65162-415-03 30 TABLET in 1 BOTTLE (65162-415-03) 65162-415-09 90 TABLET in 1 BOTTLE (65162-415-09)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride dihydrate (2 mg/1)

Linked Drug Pages (1)

Buprenorphine HCl and Naloxone HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "4cea862f-8edf-4035-a7f5-328beff51a29", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["17b63f10-c9df-44be-80fa-6f1c305583b8"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-415-03)", "package_ndc": "65162-415-03", "marketing_start_date": "20130222"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-415-09)", "package_ndc": "65162-415-09", "marketing_start_date": "20130222"}], "brand_name": "Buprenorphine HCl and Naloxone HCl", "product_id": "65162-415_4cea862f-8edf-4035-a7f5-328beff51a29", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "65162-415", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine HCl and Naloxone HCl", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA203136", "marketing_category": "ANDA", "marketing_start_date": "20130222", "listing_expiration_date": "20271231"}