buprenorphine hcl

Generic: buprenorphine hcl

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hcl
Generic Name buprenorphine hcl
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2014
Product ID 70518-2014_498bf1a2-fabc-0a31-e063-6294a90a6e94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078633
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2019-04-12

Pharmacologic Class

Classes
partial opioid agonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705182014
Hyphenated Format 70518-2014

Supplemental Identifiers

RxCUI
351265
UNII
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 hcl (source: ndc)
Generic Name buprenorphine hcl (source: ndc)
Application Number ANDA078633 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-2014-0)
source: ndc

Packages (1)

70518-2014-0 30 TABLET in 1 BLISTER PACK (70518-2014-0)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

Buprenorphine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "498bf1a2-fabc-0a31-e063-6294a90a6e94", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351265"], "spl_set_id": ["69a647c0-bc09-4ee2-aeb3-ef286caf25e5"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-2014-0)", "package_ndc": "70518-2014-0", "marketing_start_date": "20190412"}], "brand_name": "Buprenorphine HCl", "product_id": "70518-2014_498bf1a2-fabc-0a31-e063-6294a90a6e94", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "70518-2014", "dea_schedule": "CIII", "generic_name": "Buprenorphine HCl", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine HCl", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078633", "marketing_category": "ANDA", "marketing_start_date": "20190412", "listing_expiration_date": "20271231"}