Package 0054-0188-13
Brand: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydratePackage 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
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"}