belbuca

Generic: buprenorphine hydrochloride

Labeler: biodelivery sciences international inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name belbuca
Generic Name buprenorphine hydrochloride
Labeler biodelivery sciences international inc
Dosage Form FILM, SOLUBLE
Routes
BUCCAL
Active Ingredients

buprenorphine hydrochloride 75 ug/1

Manufacturer
BioDelivery Sciences International Inc

Identifiers & Regulatory

Product NDC 59385-021
Product ID 59385-021_16403e7a-5881-43d2-990c-a7d673971c3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207932
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2017-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59385021
Hyphenated Format 59385-021

Supplemental Identifiers

RxCUI
1716057 1716063 1716065 1716067 1716069 1716071 1716073 1716075 1716077 1716079 1716081 1716083 1716086 1716090
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 belbuca (source: ndc)
Generic Name buprenorphine hydrochloride (source: ndc)
Application Number NDA207932 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 75 ug/1
source: ndc
Packaging
  • 60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01)
source: ndc

Packages (1)

59385-021-60 60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01)

Ingredients (1)

buprenorphine hydrochloride (75 ug/1)

Linked Drug Pages (1)

BELBUCA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "16403e7a-5881-43d2-990c-a7d673971c3d", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["1716057", "1716063", "1716065", "1716067", "1716069", "1716071", "1716073", "1716075", "1716077", "1716079", "1716081", "1716083", "1716086", "1716090"], "spl_set_id": ["bc2b7a3d-72cf-497c-95b0-ba2b71f63c64"], "manufacturer_name": ["BioDelivery Sciences International Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 CARTON (59385-021-60)  / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01)", "package_ndc": "59385-021-60", "marketing_start_date": "20170901"}], "brand_name": "BELBUCA", "product_id": "59385-021_16403e7a-5881-43d2-990c-a7d673971c3d", "dosage_form": "FILM, SOLUBLE", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "59385-021", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride", "labeler_name": "BioDelivery Sciences International Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BELBUCA", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "75 ug/1"}], "application_number": "NDA207932", "marketing_category": "NDA", "marketing_start_date": "20170901", "listing_expiration_date": "20271231"}