hydromorphone hydrochloride (63323-851)

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride

Generic Name hydromorphone hydrochloride

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

Active Ingredients

hydromorphone hydrochloride 10 mg/mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-851

Product ID 63323-851_9e8522c6-595c-46f9-bb25-272aa4683e0f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA019034

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2017-12-15

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323851

Hyphenated Format 63323-851

Supplemental Identifiers

RxCUI

897653 897753 1724276 1724338 1724340 1724341

UPC

0363323851507 0363323853037 0363323852030 0363323851071 0363323854034 0363323851033

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 NDA019034 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03)
10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07)
50 mL in 1 VIAL, SINGLE-DOSE (63323-851-50)

source: ndc

Packages (3)

63323-851-10 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03) 63323-851-15 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07) 63323-851-50 50 mL in 1 VIAL, SINGLE-DOSE (63323-851-50)

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": "9e8522c6-595c-46f9-bb25-272aa4683e0f", "openfda": {"upc": ["0363323851507", "0363323853037", "0363323852030", "0363323851071", "0363323854034", "0363323851033"], "unii": ["L960UP2KRW"], "rxcui": ["897653", "897753", "1724276", "1724338", "1724340", "1724341"], "spl_set_id": ["e034eb96-03e0-46e1-8b92-5e1f94555e7b"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03)", "package_ndc": "63323-851-10", "marketing_start_date": "20171215"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-15)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07)", "package_ndc": "63323-851-15", "marketing_start_date": "20171215"}, {"sample": false, "description": "50 mL in 1 VIAL, SINGLE-DOSE (63323-851-50)", "package_ndc": "63323-851-50", "marketing_start_date": "20171215"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "63323-851_9e8522c6-595c-46f9-bb25-272aa4683e0f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63323-851", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA019034", "marketing_category": "NDA", "marketing_start_date": "20171215", "listing_expiration_date": "20261231"}