butorphanol tartrate

Generic: butorphanol tartrate

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

Drug Facts

Product Profile

Brand Name butorphanol tartrate
Generic Name butorphanol tartrate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

butorphanol tartrate 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9867
Product ID 0143-9867_b7be42f0-5b59-4a5a-a667-dfa81ff08b2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078400
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2009-05-01

Pharmacologic Class

Classes
competitive opioid antagonists [moa] opioid agonist/antagonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439867
Hyphenated Format 0143-9867

Supplemental Identifiers

RxCUI
886627 1728351
UNII
2L7I72RUHN

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 butorphanol tartrate (source: ndc)
Generic Name butorphanol tartrate (source: ndc)
Application Number ANDA078400 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (0143-9867-10)
source: ndc

Packages (1)

0143-9867-10 1 mL in 1 VIAL, SINGLE-DOSE (0143-9867-10)

Ingredients (1)

butorphanol tartrate (2 mg/mL)

Linked Drug Pages (1)

Butorphanol Tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "b7be42f0-5b59-4a5a-a667-dfa81ff08b2a", "openfda": {"unii": ["2L7I72RUHN"], "rxcui": ["886627", "1728351"], "spl_set_id": ["bded5531-8847-4576-9a29-3e44f979d2e0"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (0143-9867-10)", "package_ndc": "0143-9867-10", "marketing_start_date": "20090501"}], "brand_name": "Butorphanol Tartrate", "product_id": "0143-9867_b7be42f0-5b59-4a5a-a667-dfa81ff08b2a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0143-9867", "dea_schedule": "CIV", "generic_name": "Butorphanol Tartrate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butorphanol Tartrate", "active_ingredients": [{"name": "BUTORPHANOL TARTRATE", "strength": "2 mg/mL"}], "application_number": "ANDA078400", "marketing_category": "ANDA", "marketing_start_date": "20090501", "listing_expiration_date": "20261231"}