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 INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

hydromorphone hydrochloride .5 mg/.5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6206
Product ID 0641-6206_08fdd324-f2ce-4a29-a6d1-fc88aa10b7ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216899
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-04-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416206
Hyphenated Format 0641-6206

Supplemental Identifiers

RxCUI
897756 897757 1433251 2277368
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 ANDA216899 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/.5mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (0641-6206-10) / .5 mL in 1 SYRINGE (0641-6206-01)
source: ndc

Packages (1)

0641-6206-10 10 SYRINGE in 1 CARTON (0641-6206-10) / .5 mL in 1 SYRINGE (0641-6206-01)

Ingredients (1)

hydromorphone hydrochloride (.5 mg/.5mL)

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": "08fdd324-f2ce-4a29-a6d1-fc88aa10b7ac", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897756", "897757", "1433251", "2277368"], "spl_set_id": ["31d5a37a-0e90-4e88-be14-75c877be9de2"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (0641-6206-10)  / .5 mL in 1 SYRINGE (0641-6206-01)", "package_ndc": "0641-6206-10", "marketing_start_date": "20240426"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0641-6206_08fdd324-f2ce-4a29-a6d1-fc88aa10b7ac", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6206", "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": ".5 mg/.5mL"}], "application_number": "ANDA216899", "marketing_category": "ANDA", "marketing_start_date": "20240426", "listing_expiration_date": "20261231"}