hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

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

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydromorphone hydrochloride 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0386
Product ID 0054-0386_4c3c8198-731d-4136-9222-01063f3364cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074653
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2012-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540386
Hyphenated Format 0054-0386

Supplemental Identifiers

RxCUI
897657 897702 897710
UPC
0300540386634
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 ANDA074653 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0054-0386-63)
source: ndc

Packages (1)

0054-0386-63 473 mL in 1 BOTTLE (0054-0386-63)

Ingredients (1)

hydromorphone hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Hydromorphone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c3c8198-731d-4136-9222-01063f3364cb", "openfda": {"upc": ["0300540386634"], "unii": ["L960UP2KRW"], "rxcui": ["897657", "897702", "897710"], "spl_set_id": ["cc574063-6ede-4da7-82c4-7450c92b229b"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0054-0386-63)", "package_ndc": "0054-0386-63", "marketing_start_date": "20120301"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0054-0386_4c3c8198-731d-4136-9222-01063f3364cb", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0386", "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": "1 mg/mL"}], "application_number": "ANDA074653", "marketing_category": "ANDA", "marketing_start_date": "20120301", "listing_expiration_date": "20271231"}