hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

hydromorphone hydrochloride 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6254
Product ID 0641-6254_ba25ec4f-3b81-4960-bf74-6a1e4c6be45c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217812
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416254
Hyphenated Format 0641-6254

Supplemental Identifiers

RxCUI
897745
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 NDA217812 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

0641-6254-01 1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL

Ingredients (1)

hydromorphone hydrochloride (2 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": "ba25ec4f-3b81-4960-bf74-6a1e4c6be45c", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897745"], "spl_set_id": ["c729424e-e483-4bf8-b86c-ce56636dcffa"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0641-6254-01)  / 20 mL in 1 VIAL", "package_ndc": "0641-6254-01", "marketing_start_date": "20250513"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0641-6254_ba25ec4f-3b81-4960-bf74-6a1e4c6be45c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6254", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "NDA217812", "marketing_category": "NDA", "marketing_start_date": "20250513", "listing_expiration_date": "20261231"}