dilaudid

Generic: hydromorphone hydrochloride

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

Drug Facts

Product Profile

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

hydromorphone hydrochloride 8 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-338
Product ID 42858-338_00a91762-5403-413c-b3f8-3b4e73684c4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019892
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2017-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858338
Hyphenated Format 42858-338

Supplemental Identifiers

RxCUI
897657 897658 897696 897698 897702 897704 897710 897712
UPC
0342858234016 0342858122016 0342858338011
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 NDA019892 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (42858-338-01)
source: ndc

Packages (1)

42858-338-01 100 TABLET in 1 BOTTLE, PLASTIC (42858-338-01)

Ingredients (1)

hydromorphone hydrochloride (8 mg/1)

Linked Drug Pages (1)

Dilaudid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00a91762-5403-413c-b3f8-3b4e73684c4f", "openfda": {"upc": ["0342858234016", "0342858122016", "0342858338011"], "unii": ["L960UP2KRW"], "rxcui": ["897657", "897658", "897696", "897698", "897702", "897704", "897710", "897712"], "spl_set_id": ["d6b40e39-a57e-402c-b4f6-7041e832f837"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (42858-338-01)", "package_ndc": "42858-338-01", "marketing_start_date": "20170515"}], "brand_name": "Dilaudid", "product_id": "42858-338_00a91762-5403-413c-b3f8-3b4e73684c4f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42858-338", "dea_schedule": "CII", "generic_name": "hydromorphone hydrochloride", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dilaudid", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "NDA019892", "marketing_category": "NDA", "marketing_start_date": "20170515", "listing_expiration_date": "20271231"}