buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler mylan pharmaceuticals inc.
Dosage Form FILM
Routes
BUCCAL SUBLINGUAL
Active Ingredients

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

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8766
Product ID 0378-8766_008d89ec-5bd7-46d9-bc94-9cdc7405f95d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211785
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2020-04-17

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 03788766
Hyphenated Format 0378-8766

Supplemental Identifiers

RxCUI
1010600 1010604 1307056 1307061
UNII
5Q187997EE 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 buprenorphine and naloxone (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA211785 (source: ndc)
Routes
BUCCAL SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (0378-8766-93) / 1 FILM in 1 POUCH (0378-8766-16)
source: ndc

Packages (1)

0378-8766-93 30 POUCH in 1 CARTON (0378-8766-93) / 1 FILM in 1 POUCH (0378-8766-16)

Ingredients (2)

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

Linked Drug Pages (1)

Buprenorphine and Naloxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL", "SUBLINGUAL"], "spl_id": "008d89ec-5bd7-46d9-bc94-9cdc7405f95d", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["1010600", "1010604", "1307056", "1307061"], "spl_set_id": ["557d8d4d-8751-431c-b18e-9d5cf23fc579"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0378-8766-93)  / 1 FILM in 1 POUCH (0378-8766-16)", "package_ndc": "0378-8766-93", "marketing_start_date": "20200417"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "0378-8766_008d89ec-5bd7-46d9-bc94-9cdc7405f95d", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0378-8766", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "4 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "1 mg/1"}], "application_number": "ANDA211785", "marketing_category": "ANDA", "marketing_start_date": "20200417", "listing_expiration_date": "20271231"}