buprenorphine

Generic: buprenorphine

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler amneal pharmaceuticals ny llc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

buprenorphine 5 ug/h

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1202
Product ID 69238-1202_5b776a17-f8cd-413d-934b-fcbe0de7f8d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211586
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2020-04-20

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 692381202
Hyphenated Format 69238-1202

Supplemental Identifiers

RxCUI
904870 904876 904880 1432969 1542997
UPC
0369238120325 0369238120226 0369238120523 0369238150520 0369238120424
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 ANDA211586 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 5 ug/h
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (69238-1202-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
source: ndc

Packages (1)

69238-1202-2 4 POUCH in 1 CARTON (69238-1202-2) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Ingredients (1)

buprenorphine (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": "5b776a17-f8cd-413d-934b-fcbe0de7f8d4", "openfda": {"nui": ["N0000175689", "N0000175685"], "upc": ["0369238120325", "0369238120226", "0369238120523", "0369238150520", "0369238120424"], "unii": ["40D3SCR4GZ"], "rxcui": ["904870", "904876", "904880", "1432969", "1542997"], "spl_set_id": ["c7d079fb-507f-436f-b794-2171b7d97067"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (69238-1202-2)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH", "package_ndc": "69238-1202-2", "marketing_start_date": "20200420"}], "brand_name": "Buprenorphine", "product_id": "69238-1202_5b776a17-f8cd-413d-934b-fcbe0de7f8d4", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "69238-1202", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "5 ug/h"}], "application_number": "ANDA211586", "marketing_category": "ANDA", "marketing_start_date": "20200420", "listing_expiration_date": "20271231"}