buprenorphine and naloxone sublingual film

Generic: buprenorphine and naloxone

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

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone sublingual film
Generic Name buprenorphine and naloxone
Labeler alvogen inc.
Dosage Form FILM
Routes
BUCCAL SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 2 mg/1, naloxone hydrochloride dihydrate .5 mg/1

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-355
Product ID 47781-355_afb884aa-0110-dd76-ba93-6dfcbe806f97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205954
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-02-11

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 47781355
Hyphenated Format 47781-355

Supplemental Identifiers

RxCUI
1010600 1010604 1307056 1307061
UPC
0347781356118 0347781358037 0347781355036 0347781357030 0347781356033 0347781358112 0347781357115 0347781355111
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 sublingual film (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA205954 (source: ndc)
Routes
BUCCAL SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (47781-355-03) / 1 FILM in 1 POUCH (47781-355-11)
source: ndc

Packages (1)

47781-355-03 30 POUCH in 1 CARTON (47781-355-03) / 1 FILM in 1 POUCH (47781-355-11)

Ingredients (2)

buprenorphine hydrochloride (2 mg/1) naloxone hydrochloride dihydrate (.5 mg/1)

Linked Drug Pages (1)

Buprenorphine and Naloxone Sublingual Film ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL", "SUBLINGUAL"], "spl_id": "afb884aa-0110-dd76-ba93-6dfcbe806f97", "openfda": {"upc": ["0347781356118", "0347781358037", "0347781355036", "0347781357030", "0347781356033", "0347781358112", "0347781357115", "0347781355111"], "unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["1010600", "1010604", "1307056", "1307061"], "spl_set_id": ["4210afeb-474c-d842-d68e-af7e0021851a"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (47781-355-03)  / 1 FILM in 1 POUCH (47781-355-11)", "package_ndc": "47781-355-03", "marketing_start_date": "20190211"}], "brand_name": "Buprenorphine and Naloxone Sublingual Film", "product_id": "47781-355_afb884aa-0110-dd76-ba93-6dfcbe806f97", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "47781-355", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "brand_name_suffix": "Sublingual Film", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA205954", "marketing_category": "ANDA", "marketing_start_date": "20190211", "listing_expiration_date": "20261231"}