Package 0054-0188-13

Brand: buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
NDC Package

Package Facts

Identity

Package NDC 0054-0188-13
Digits Only 0054018813
Product NDC 0054-0188
Description

30 TABLET in 1 BOTTLE (0054-0188-13)

Marketing

Marketing Status
Marketed Since 2014-06-27
Brand buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["SUBLINGUAL"], "spl_id": "baa6b446-3f71-42c6-a9bb-8526e8f9e81c", "openfda": {"upc": ["0300540189136", "0300540188139"], "unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["713db2c6-0544-4633-b874-cfbeaf93db89"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0054-0188-13)", "package_ndc": "0054-0188-13", "marketing_start_date": "20140627"}], "brand_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "product_id": "0054-0188_baa6b446-3f71-42c6-a9bb-8526e8f9e81c", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0054-0188", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA203326", "marketing_category": "ANDA", "marketing_start_date": "20140627", "listing_expiration_date": "20271231"}