buprenorphine hydrochloride

Generic: buprenorphine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hydrochloride
Generic Name buprenorphine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

buprenorphine hydrochloride .324 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-027
Product ID 70069-027_abc53fa8-3d75-47b5-bfb1-d61872c1ddb4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219302
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-02-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069027
Hyphenated Format 70069-027

Supplemental Identifiers

RxCUI
238129
UPC
0370069027059 0370069027011
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 ANDA219302 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .324 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (70069-027-05) / 1 mL in 1 VIAL
source: ndc

Packages (1)

70069-027-05 5 VIAL in 1 CARTON (70069-027-05) / 1 mL in 1 VIAL

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": "abc53fa8-3d75-47b5-bfb1-d61872c1ddb4", "openfda": {"upc": ["0370069027059", "0370069027011"], "unii": ["56W8MW3EN1"], "rxcui": ["238129"], "spl_set_id": ["74e40c51-853b-4e7f-b3cb-a27af29e1cbf"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (70069-027-05)  / 1 mL in 1 VIAL", "package_ndc": "70069-027-05", "marketing_start_date": "20250211"}], "brand_name": "Buprenorphine Hydrochloride", "product_id": "70069-027_abc53fa8-3d75-47b5-bfb1-d61872c1ddb4", "dosage_form": "INJECTION", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "70069-027", "dea_schedule": "CIII", "generic_name": "Buprenorphine Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine Hydrochloride", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": ".324 mg/mL"}], "application_number": "ANDA219302", "marketing_category": "ANDA", "marketing_start_date": "20250211", "listing_expiration_date": "20261231"}