buprenorphine and naloxone sublingual film

Generic: buprenorphine and naloxone

Labeler: redpharm drug
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 redpharm drug
Dosage Form FILM
Routes
BUCCAL SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1, naloxone hydrochloride dihydrate 2 mg/1

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-1933
Product ID 67296-1933_46e93923-334d-68db-e063-6394a90ad902
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 672961933
Hyphenated Format 67296-1933

Supplemental Identifiers

RxCUI
1010604
UPC
0347781356118 0347781358037 0347781355036 0347781357030 0347781356033 0347781358112 0347781357115 0347781355111
UNII
56W8MW3EN1 5Q187997EE

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
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (67296-1933-1) / 1 FILM in 1 POUCH
  • 9 POUCH in 1 CARTON (67296-1933-9) / 1 FILM in 1 POUCH
source: ndc

Packages (2)

67296-1933-1 1 POUCH in 1 CARTON (67296-1933-1) / 1 FILM in 1 POUCH 67296-1933-9 9 POUCH in 1 CARTON (67296-1933-9) / 1 FILM in 1 POUCH

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride dihydrate (2 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": "46e93923-334d-68db-e063-6394a90ad902", "openfda": {"upc": ["0347781356118", "0347781358037", "0347781355036", "0347781357030", "0347781356033", "0347781358112", "0347781357115", "0347781355111"], "unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["1010604"], "spl_set_id": ["2fd16916-95a9-14b5-e063-6294a90a79fa"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (67296-1933-1)  / 1 FILM in 1 POUCH", "package_ndc": "67296-1933-1", "marketing_start_date": "20190211"}, {"sample": false, "description": "9 POUCH in 1 CARTON (67296-1933-9)  / 1 FILM in 1 POUCH", "package_ndc": "67296-1933-9", "marketing_start_date": "20190211"}], "brand_name": "Buprenorphine and Naloxone Sublingual Film", "product_id": "67296-1933_46e93923-334d-68db-e063-6394a90ad902", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "67296-1933", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "brand_name_suffix": "Sublingual Film", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA205954", "marketing_category": "ANDA", "marketing_start_date": "20190211", "listing_expiration_date": "20261231"}