buprenorphine

Generic: buprenorphine

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler rhodes pharmaceuticals l.p.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 2 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-501
Product ID 42858-501_db126900-5151-4563-9e39-55caaeada4ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207276
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2017-10-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858501
Hyphenated Format 42858-501

Supplemental Identifiers

RxCUI
351264 351265
UPC
0342858501033 0342858502030
UNII
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 (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number ANDA207276 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42858-501-03)
source: ndc

Packages (1)

42858-501-03 30 TABLET in 1 BOTTLE (42858-501-03)

Ingredients (1)

buprenorphine hydrochloride (2 mg/1)

Linked Drug Pages (1)

BUPRENORPHINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "db126900-5151-4563-9e39-55caaeada4ea", "openfda": {"upc": ["0342858501033", "0342858502030"], "unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["da90618a-5621-4b15-bc48-9dcc631418de"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42858-501-03)", "package_ndc": "42858-501-03", "marketing_start_date": "20171025"}], "brand_name": "BUPRENORPHINE", "product_id": "42858-501_db126900-5151-4563-9e39-55caaeada4ea", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "42858-501", "dea_schedule": "CIII", "generic_name": "BUPRENORPHINE", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPRENORPHINE", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA207276", "marketing_category": "ANDA", "marketing_start_date": "20171025", "listing_expiration_date": "20271231"}