buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler dr.reddys laboratories inc
Dosage Form FILM, SOLUBLE
Routes
BUCCAL SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 12 mg/1, naloxone 3 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-581
Product ID 43598-581_af3c8314-5a38-2103-6ef8-94f179ffd541
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205806
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2018-06-14

Pharmacologic Class

Established (EPC)
opioid antagonist [epc]
Mechanism of Action
opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598581
Hyphenated Format 43598-581

Supplemental Identifiers

RxCUI
1307056 1307061
UPC
0343598580012
UNII
36B82AMQ7N 56W8MW3EN1
NUI
N0000175691 N0000000154

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 ANDA205806 (source: ndc)
Routes
BUCCAL SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
  • 3 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (43598-581-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-581-01)
source: ndc

Packages (1)

43598-581-30 30 POUCH in 1 CARTON (43598-581-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-581-01)

Ingredients (2)

buprenorphine hydrochloride (12 mg/1) naloxone (3 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": "af3c8314-5a38-2103-6ef8-94f179ffd541", "openfda": {"nui": ["N0000175691", "N0000000154"], "upc": ["0343598580012"], "unii": ["36B82AMQ7N", "56W8MW3EN1"], "rxcui": ["1307056", "1307061"], "spl_set_id": ["72dc1ec0-7c59-a587-4ffd-c40ef79e6fb2"], "pharm_class_epc": ["Opioid Antagonist [EPC]"], "pharm_class_moa": ["Opioid Antagonists [MoA]"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (43598-581-30)  / 1 FILM, SOLUBLE in 1 POUCH (43598-581-01)", "package_ndc": "43598-581-30", "marketing_start_date": "20180614"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "43598-581_af3c8314-5a38-2103-6ef8-94f179ffd541", "dosage_form": "FILM, SOLUBLE", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "43598-581", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "12 mg/1"}, {"name": "NALOXONE", "strength": "3 mg/1"}], "application_number": "ANDA205806", "marketing_category": "ANDA", "marketing_start_date": "20180614", "listing_expiration_date": "20271231"}