buprenorphine

Generic: buprenorphine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-460
Product ID 62756-460_ba293490-0f6f-4400-82cd-3af9774839e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201760
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2016-02-17

Pharmacologic Class

Classes
partial opioid agonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756460
Hyphenated Format 62756-460

Supplemental Identifiers

RxCUI
351264 351265
UNII
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 (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number ANDA201760 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (62756-460-64) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (62756-460-83)
source: ndc

Packages (2)

62756-460-64 3 BLISTER PACK in 1 CARTON (62756-460-64) / 10 TABLET in 1 BLISTER PACK 62756-460-83 30 TABLET in 1 BOTTLE (62756-460-83)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

Buprenorphine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "ba293490-0f6f-4400-82cd-3af9774839e8", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["9fd1f18f-0b0f-4059-b603-19ecbf0ed63a"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (62756-460-64)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "62756-460-64", "marketing_start_date": "20160217"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (62756-460-83)", "package_ndc": "62756-460-83", "marketing_start_date": "20160217"}], "brand_name": "Buprenorphine", "product_id": "62756-460_ba293490-0f6f-4400-82cd-3af9774839e8", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "62756-460", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA201760", "marketing_category": "ANDA", "marketing_start_date": "20160217", "listing_expiration_date": "20271231"}