buprenorphine

Generic: buprenorphine

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler rhodes pharmaceuticals l.p.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

buprenorphine 7.5 ug/h

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-353
Product ID 42858-353_ba2ef30d-128a-423e-bfc2-d1896c5bd6bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021306
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2017-07-03

Pharmacologic Class

Established (EPC)
partial opioid agonist [epc]
Mechanism of Action
partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858353
Hyphenated Format 42858-353

Supplemental Identifiers

RxCUI
904870 904876 904880 1432969 1542997
UNII
40D3SCR4GZ
NUI
N0000175689 N0000175685

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 NDA021306 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 7.5 ug/h
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (42858-353-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
source: ndc

Packages (1)

42858-353-40 4 POUCH in 1 CARTON (42858-353-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Ingredients (1)

buprenorphine (7.5 ug/h)

Linked Drug Pages (1)

Buprenorphine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "ba2ef30d-128a-423e-bfc2-d1896c5bd6bb", "openfda": {"nui": ["N0000175689", "N0000175685"], "unii": ["40D3SCR4GZ"], "rxcui": ["904870", "904876", "904880", "1432969", "1542997"], "spl_set_id": ["2738feae-316e-426f-971c-5f142ac01b60"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (42858-353-40)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH", "package_ndc": "42858-353-40", "marketing_start_date": "20170705"}], "brand_name": "Buprenorphine", "product_id": "42858-353_ba2ef30d-128a-423e-bfc2-d1896c5bd6bb", "dosage_form": "PATCH", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "42858-353", "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", "strength": "7.5 ug/h"}], "application_number": "NDA021306", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20170703", "listing_expiration_date": "20271231"}