buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler american health packaging
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-637
Product ID 60687-637_202259e2-8dae-1a15-e063-6394a90a1020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205601
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-03-14

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 60687637
Hyphenated Format 60687-637

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 and naloxone (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA205601 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (60687-637-65) / 1 TABLET in 1 BLISTER PACK (60687-637-11)
source: ndc

Packages (1)

60687-637-65 50 BLISTER PACK in 1 CARTON (60687-637-65) / 1 TABLET in 1 BLISTER PACK (60687-637-11)

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": "202259e2-8dae-1a15-e063-6394a90a1020", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["b05b0087-c0ef-40be-9bf3-3933f6cd3492"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (60687-637-65)  / 1 TABLET in 1 BLISTER PACK (60687-637-11)", "package_ndc": "60687-637-65", "marketing_start_date": "20220314"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "60687-637_202259e2-8dae-1a15-e063-6394a90a1020", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "60687-637", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "American Health Packaging", "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": "ANDA205601", "marketing_category": "ANDA", "marketing_start_date": "20220314", "listing_expiration_date": "20261231"}