buprenorphine hydrochloride

Generic: buprenorphine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hydrochloride
Generic Name buprenorphine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

buprenorphine hydrochloride .324 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9246
Product ID 0143-9246_8ba9787c-d429-4a5d-8424-e13be15cb9f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076931
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2005-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439246
Hyphenated Format 0143-9246

Supplemental Identifiers

RxCUI
238129
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 hydrochloride (source: ndc)
Generic Name buprenorphine hydrochloride (source: ndc)
Application Number ANDA076931 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .324 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (0143-9246-05) / 1 mL in 1 VIAL (0143-9246-01)
source: ndc

Packages (1)

0143-9246-05 5 VIAL in 1 CARTON (0143-9246-05) / 1 mL in 1 VIAL (0143-9246-01)

Ingredients (1)

buprenorphine hydrochloride (.324 mg/mL)

Linked Drug Pages (1)

Buprenorphine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "8ba9787c-d429-4a5d-8424-e13be15cb9f1", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["238129"], "spl_set_id": ["adc1167e-910e-4d7b-abdc-751d3df0c3dc"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (0143-9246-05)  / 1 mL in 1 VIAL (0143-9246-01)", "package_ndc": "0143-9246-05", "marketing_start_date": "20190712"}], "brand_name": "Buprenorphine Hydrochloride", "product_id": "0143-9246_8ba9787c-d429-4a5d-8424-e13be15cb9f1", "dosage_form": "INJECTION", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0143-9246", "dea_schedule": "CIII", "generic_name": "Buprenorphine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine Hydrochloride", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": ".324 mg/mL"}], "application_number": "ANDA076931", "marketing_category": "ANDA", "marketing_start_date": "20050525", "listing_expiration_date": "20261231"}