suboxone

Generic: buprenorphine hydrochloride, naloxone hydrochloride

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

Drug Facts

Product Profile

Brand Name suboxone
Generic Name buprenorphine hydrochloride, naloxone hydrochloride
Labeler indivior inc.
Dosage Form FILM, SOLUBLE
Routes
BUCCAL SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 4 mg/1, naloxone hydrochloride 1 mg/1

Manufacturer
INDIVIOR INC.

Identifiers & Regulatory

Product NDC 12496-1204
Product ID 12496-1204_ad5a289a-6285-4b2d-b7ad-e4812169dd58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022410
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2012-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 124961204
Hyphenated Format 12496-1204

Supplemental Identifiers

RxCUI
1010600 1010603 1010604 1010606 1307056 1307058 1307061 1307063
UPC
0312496120835
UNII
56W8MW3EN1 F850569PQR

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 suboxone (source: ndc)
Generic Name buprenorphine hydrochloride, naloxone hydrochloride (source: ndc)
Application Number NDA022410 (source: ndc)
Routes
BUCCAL SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (12496-1204-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1)
source: ndc

Packages (1)

12496-1204-3 30 POUCH in 1 CARTON (12496-1204-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1)

Ingredients (2)

buprenorphine hydrochloride (4 mg/1) naloxone hydrochloride (1 mg/1)

Linked Drug Pages (1)

Suboxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL", "SUBLINGUAL"], "spl_id": "ad5a289a-6285-4b2d-b7ad-e4812169dd58", "openfda": {"upc": ["0312496120835"], "unii": ["56W8MW3EN1", "F850569PQR"], "rxcui": ["1010600", "1010603", "1010604", "1010606", "1307056", "1307058", "1307061", "1307063"], "spl_set_id": ["8a5edcf9-828c-4f97-b671-268ab13a8ecd"], "manufacturer_name": ["INDIVIOR INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (12496-1204-3)  / 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1)", "package_ndc": "12496-1204-3", "marketing_start_date": "20120824"}], "brand_name": "Suboxone", "product_id": "12496-1204_ad5a289a-6285-4b2d-b7ad-e4812169dd58", "dosage_form": "FILM, SOLUBLE", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "12496-1204", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride, naloxone hydrochloride", "labeler_name": "INDIVIOR INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Suboxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "4 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "NDA022410", "marketing_category": "NDA", "marketing_start_date": "20120824", "listing_expiration_date": "20271231"}