hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler rhodes pharmaceuticals l.p.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydromorphone hydrochloride 5 mg/5mL

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-304
Product ID 42858-304_89fd335d-5306-4573-afca-5fdc8a25cb30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019891
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2012-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858304
Hyphenated Format 42858-304

Supplemental Identifiers

RxCUI
897657 897696 897702 897710
UPC
0342858303019 0342858301015 0342858302012
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 NDA019891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (42858-304-16)
source: ndc

Packages (1)

42858-304-16 473 mL in 1 BOTTLE, PLASTIC (42858-304-16)

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": ["ORAL"], "spl_id": "89fd335d-5306-4573-afca-5fdc8a25cb30", "openfda": {"upc": ["0342858303019", "0342858301015", "0342858302012"], "unii": ["L960UP2KRW"], "rxcui": ["897657", "897696", "897702", "897710"], "spl_set_id": ["37565441-0d95-4743-a695-d7b3326f58a1"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (42858-304-16)", "package_ndc": "42858-304-16", "marketing_start_date": "20120720"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "42858-304_89fd335d-5306-4573-afca-5fdc8a25cb30", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42858-304", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "NDA019891", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20120720", "listing_expiration_date": "20271231"}