hydromorphone hydrochloride (0409-2634)

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 10 mg/mL

Manufacturer

Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-2634

Product ID 0409-2634_f0c8c83c-fb41-4571-a72e-6542311351dd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078591

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2008-07-31

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04092634

Hyphenated Format 0409-2634

Supplemental Identifiers

RxCUI

1724338 1724340 1724341

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 ANDA078591 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10)
10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25)
1 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-50) / 50 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (3)

0409-2634-01 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10) 0409-2634-05 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25) 0409-2634-50 1 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

hydromorphone hydrochloride (10 mg/mL)

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": "f0c8c83c-fb41-4571-a72e-6542311351dd", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["1724338", "1724340", "1724341"], "spl_set_id": ["3832ede8-d3fc-455d-ecab-3b77be5869f5"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10)", "package_ndc": "0409-2634-01", "marketing_start_date": "20080808"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25)", "package_ndc": "0409-2634-05", "marketing_start_date": "20080807"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0409-2634-50", "marketing_start_date": "20080731"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0409-2634_f0c8c83c-fb41-4571-a72e-6542311351dd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0409-2634", "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": "10 mg/mL"}], "application_number": "ANDA078591", "marketing_category": "ANDA", "marketing_start_date": "20080731", "listing_expiration_date": "20261231"}