buprenorphine hydrochloride

Generic: buprenorphine hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hydrochloride
Generic Name buprenorphine hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

buprenorphine hydrochloride .3 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-2012
Product ID 0409-2012_37d2deb6-c54a-42bb-ad76-4873a59da562
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074137
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2005-06-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04092012
Hyphenated Format 0409-2012

Supplemental Identifiers

RxCUI
1655032
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 ANDA074137 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .3 mg/mL
source: ndc
Packaging
  • 10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03)
source: ndc

Packages (1)

0409-2012-32 10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03)

Ingredients (1)

buprenorphine hydrochloride (.3 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": "37d2deb6-c54a-42bb-ad76-4873a59da562", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["1655032"], "spl_set_id": ["23aa1bb3-cecf-4e62-29bb-48488bb66fc3"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTRIDGE in 1 CARTON (0409-2012-32)  / 1 mL in 1 CARTRIDGE (0409-2012-03)", "package_ndc": "0409-2012-32", "marketing_start_date": "20050614"}], "brand_name": "Buprenorphine Hydrochloride", "product_id": "0409-2012_37d2deb6-c54a-42bb-ad76-4873a59da562", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0409-2012", "dea_schedule": "CIII", "generic_name": "Buprenorphine Hydrochloride", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine Hydrochloride", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": ".3 mg/mL"}], "application_number": "ANDA074137", "marketing_category": "ANDA", "marketing_start_date": "20050614", "listing_expiration_date": "20261231"}