hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

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 4 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-854
Product ID 63323-854_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 63323854
Hyphenated Format 63323-854

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
  • 4 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-854-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-854-03)
source: ndc

Packages (1)

63323-854-10 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-854-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-854-03)

Ingredients (1)

hydromorphone hydrochloride (4 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": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-854-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-854-03)", "package_ndc": "63323-854-10", "marketing_start_date": "20171215"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "63323-854_9e8522c6-595c-46f9-bb25-272aa4683e0f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63323-854", "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": "4 mg/mL"}], "application_number": "NDA019034", "marketing_category": "NDA", "marketing_start_date": "20171215", "listing_expiration_date": "20261231"}