buprenorphine

Generic: buprenorphine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler teva pharmaceuticals usa, inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

buprenorphine 10 ug/h

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-3657
Product ID 0093-3657_192dd133-b93c-43a0-80be-550b6e771c4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204937
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2018-11-26

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 00933657
Hyphenated Format 0093-3657

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 ANDA204937 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/h
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (0093-3657-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
source: ndc

Packages (1)

0093-3657-40 4 POUCH in 1 CARTON (0093-3657-40) / 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": "192dd133-b93c-43a0-80be-550b6e771c4f", "openfda": {"nui": ["N0000175689", "N0000175685"], "unii": ["40D3SCR4GZ"], "rxcui": ["904870", "904876", "904880", "1432969", "1542997"], "spl_set_id": ["36995ce3-b515-447b-baa9-aa14f84060d8"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (0093-3657-40)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH", "package_ndc": "0093-3657-40", "marketing_start_date": "20181126"}], "brand_name": "Buprenorphine", "product_id": "0093-3657_192dd133-b93c-43a0-80be-550b6e771c4f", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0093-3657", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "10 ug/h"}], "application_number": "ANDA204937", "marketing_category": "ANDA", "marketing_start_date": "20181126", "listing_expiration_date": "20261231"}