hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

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

Drug Facts

Product Profile

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

hydromorphone hydrochloride .5 mg/.5mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-4264
Product ID 0409-4264_766e302a-2d03-4d93-b237-2348b57ee517
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200403
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2022-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04094264
Hyphenated Format 0409-4264

Supplemental Identifiers

RxCUI
897756 897757 1433251 1724383 1724644 2675350
UNII
L960UP2KRW

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 hydromorphone hydrochloride (source: ndc)
Generic Name hydromorphone hydrochloride (source: ndc)
Application Number NDA200403 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/.5mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CELLO PACK (0409-4264-01) / .5 mL in 1 SYRINGE (0409-4264-11)
source: ndc

Packages (1)

0409-4264-01 10 SYRINGE in 1 CELLO PACK (0409-4264-01) / .5 mL in 1 SYRINGE (0409-4264-11)

Ingredients (1)

hydromorphone hydrochloride (.5 mg/.5mL)

Linked Drug Pages (1)

Hydromorphone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "766e302a-2d03-4d93-b237-2348b57ee517", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897756", "897757", "1433251", "1724383", "1724644", "2675350"], "spl_set_id": ["f9ca2ef5-46d8-475a-a26e-f7c8becd6db7"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CELLO PACK (0409-4264-01)  / .5 mL in 1 SYRINGE (0409-4264-11)", "package_ndc": "0409-4264-01", "marketing_start_date": "20220527"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0409-4264_766e302a-2d03-4d93-b237-2348b57ee517", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0409-4264", "dea_schedule": "CII", "generic_name": "HYDROMORPHONE HYDROCHLORIDE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": ".5 mg/.5mL"}], "application_number": "NDA200403", "marketing_category": "NDA", "marketing_start_date": "20220527", "listing_expiration_date": "20271231"}