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 SPRAY, METERED
Routes
NASAL
Active Ingredients

butorphanol tartrate 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3090
Product ID 0054-3090_57de4cd2-a163-4ac7-9e86-a04355a00d78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075824
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2002-03-12

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 00543090
Hyphenated Format 0054-3090

Supplemental Identifiers

RxCUI
886634
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 ANDA075824 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) / 2.5 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0054-3090-36 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) / 2.5 mL in 1 BOTTLE, SPRAY

Ingredients (1)

butorphanol tartrate (10 mg/mL)

Linked Drug Pages (1)

Butorphanol Tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "57de4cd2-a163-4ac7-9e86-a04355a00d78", "openfda": {"unii": ["2L7I72RUHN"], "rxcui": ["886634"], "spl_set_id": ["5a50d22e-acbe-4b15-9ed6-70713378408a"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36)  / 2.5 mL in 1 BOTTLE, SPRAY", "package_ndc": "0054-3090-36", "marketing_start_date": "20020312"}], "brand_name": "Butorphanol Tartrate", "product_id": "0054-3090_57de4cd2-a163-4ac7-9e86-a04355a00d78", "dosage_form": "SPRAY, METERED", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0054-3090", "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": "10 mg/mL"}], "application_number": "ANDA075824", "marketing_category": "ANDA", "marketing_start_date": "20020312", "listing_expiration_date": "20271231"}