buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-970
Product ID 62756-970_cbeda871-3722-4395-a97f-b614b5406675
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201633
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2017-07-18

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 62756970
Hyphenated Format 62756-970

Supplemental Identifiers

RxCUI
351266 351267
UPC
0362756969834
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 ANDA201633 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (62756-970-64) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (62756-970-83)
source: ndc

Packages (2)

62756-970-64 3 BLISTER PACK in 1 CARTON (62756-970-64) / 10 TABLET in 1 BLISTER PACK 62756-970-83 30 TABLET in 1 BOTTLE (62756-970-83)

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": "cbeda871-3722-4395-a97f-b614b5406675", "openfda": {"upc": ["0362756969834"], "unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["91b68606-05de-4586-ae31-07e8cc9160cf"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (62756-970-64)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "62756-970-64", "marketing_start_date": "20170718"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (62756-970-83)", "package_ndc": "62756-970-83", "marketing_start_date": "20170718"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "62756-970_cbeda871-3722-4395-a97f-b614b5406675", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "62756-970", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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": "ANDA201633", "marketing_category": "ANDA", "marketing_start_date": "20170718", "listing_expiration_date": "20271231"}