hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler padagis us llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

hydromorphone hydrochloride 12 mg/1

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0294
Product ID 0574-0294_8b576b81-17fc-4251-acc3-6e1b9e18030c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204278
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2015-05-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05740294
Hyphenated Format 0574-0294

Supplemental Identifiers

RxCUI
902729 902736 902741 1306898
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 ANDA204278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0294-01)
source: ndc

Packages (1)

0574-0294-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0294-01)

Ingredients (1)

hydromorphone hydrochloride (12 mg/1)

Linked Drug Pages (1)

hydromorphone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8b576b81-17fc-4251-acc3-6e1b9e18030c", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["902729", "902736", "902741", "1306898"], "spl_set_id": ["780a2616-0392-4715-bc50-71799bea1957"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0294-01)", "package_ndc": "0574-0294-01", "marketing_start_date": "20150522"}], "brand_name": "hydromorphone hydrochloride", "product_id": "0574-0294_8b576b81-17fc-4251-acc3-6e1b9e18030c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0574-0294", "dea_schedule": "CII", "generic_name": "hydromorphone hydrochloride", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydromorphone hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "12 mg/1"}], "application_number": "ANDA204278", "marketing_category": "ANDA", "marketing_start_date": "20150522", "listing_expiration_date": "20271231"}