buprenorphine

Generic: buprenorphine

Labeler: aveva drug delivery systems inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler aveva drug delivery systems inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

buprenorphine 10 ug/h

Manufacturer
Aveva Drug Delivery Systems Inc.

Identifiers & Regulatory

Product NDC 3215-1523
Product ID 3215-1523_3afe7c19-a042-1988-e063-6394a90a3772
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210272
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

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 32151523
Hyphenated Format 3215-1523

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 ANDA210272 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/h
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (3215-1523-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
source: ndc

Packages (1)

3215-1523-04 4 POUCH in 1 CARTON (3215-1523-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Ingredients (1)

buprenorphine (10 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": "3afe7c19-a042-1988-e063-6394a90a3772", "openfda": {"nui": ["N0000175689", "N0000175685"], "unii": ["40D3SCR4GZ"], "rxcui": ["904870", "904876", "904880", "1432969", "1542997"], "spl_set_id": ["1aae9b13-7431-42ef-8558-14a2325820e6"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Aveva Drug Delivery Systems Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (3215-1523-04)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH", "package_ndc": "3215-1523-04", "marketing_start_date": "20231101"}], "brand_name": "Buprenorphine", "product_id": "3215-1523_3afe7c19-a042-1988-e063-6394a90a3772", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "3215-1523", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Aveva Drug Delivery Systems Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "10 ug/h"}], "application_number": "ANDA210272", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}