sublocade

Generic: buprenorphine

Labeler: indivior inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sublocade
Generic Name buprenorphine
Labeler indivior inc.
Dosage Form SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

buprenorphine 300 mg/1

Manufacturer
Indivior Inc.

Identifiers & Regulatory

Product NDC 12496-0300
Product ID 12496-0300_a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209819
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2018-02-26

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 124960300
Hyphenated Format 12496-0300

Supplemental Identifiers

RxCUI
1996184 1996189 1996192 1996193
UPC
0312496030011
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 sublocade (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number NDA209819 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5)
source: ndc

Packages (1)

12496-0300-1 1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5)

Ingredients (1)

buprenorphine (300 mg/1)

Linked Drug Pages (1)

SUBLOCADE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec", "openfda": {"nui": ["N0000175689", "N0000175685"], "upc": ["0312496030011"], "unii": ["40D3SCR4GZ"], "rxcui": ["1996184", "1996189", "1996192", "1996193"], "spl_set_id": ["6189fb21-9432-45f8-8481-0bfaf3ccde95"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Indivior Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (12496-0300-1)  / 1 SYRINGE in 1 POUCH (12496-0300-2)  / 1 SOLUTION in 1 SYRINGE (12496-0300-5)", "package_ndc": "12496-0300-1", "marketing_start_date": "20180226"}], "brand_name": "SUBLOCADE", "product_id": "12496-0300_a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec", "dosage_form": "SOLUTION", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "12496-0300", "dea_schedule": "CIII", "generic_name": "buprenorphine", "labeler_name": "Indivior Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUBLOCADE", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "300 mg/1"}], "application_number": "NDA209819", "marketing_category": "NDA", "marketing_start_date": "20180226", "listing_expiration_date": "20271231"}