dilaudid

Generic: hydromorphone hydrochloride

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

Drug Facts

Product Profile

Brand Name dilaudid
Generic Name hydromorphone hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

hydromorphone hydrochloride 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-010
Product ID 76045-010_97bfcafb-2037-47dc-a0ae-f7b8007c47df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019034
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-12-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045010
Hyphenated Format 76045-010

Supplemental Identifiers

RxCUI
897756 897757 1433251 1872265 1872269 1872752 2277368 2277370
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 dilaudid (source: ndc)
Generic Name hydromorphone hydrochloride (source: ndc)
Application Number NDA019034 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (76045-010-11) / 1 mL in 1 SYRINGE (76045-010-01)
source: ndc

Packages (1)

76045-010-11 10 SYRINGE in 1 CARTON (76045-010-11) / 1 mL in 1 SYRINGE (76045-010-01)

Ingredients (1)

hydromorphone hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Dilaudid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "97bfcafb-2037-47dc-a0ae-f7b8007c47df", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897756", "897757", "1433251", "1872265", "1872269", "1872752", "2277368", "2277370"], "spl_set_id": ["9eebd88a-5632-460f-b7b6-26c8a180540d"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (76045-010-11)  / 1 mL in 1 SYRINGE (76045-010-01)", "package_ndc": "76045-010-11", "marketing_start_date": "20161216"}], "brand_name": "Dilaudid", "product_id": "76045-010_97bfcafb-2037-47dc-a0ae-f7b8007c47df", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76045-010", "dea_schedule": "CII", "generic_name": "Hydromorphone hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dilaudid", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "NDA019034", "marketing_category": "NDA", "marketing_start_date": "20161216", "listing_expiration_date": "20261231"}