hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: aurolife pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler aurolife pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydromorphone hydrochloride 4 mg/1

Manufacturer
Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-108
Product ID 13107-108_1c45740c-5fb6-4cf7-81b9-0865717334e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205814
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-05-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107108
Hyphenated Format 13107-108

Supplemental Identifiers

RxCUI
897696 897702 897710
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 ANDA205814 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-108-01)
  • 500 TABLET in 1 BOTTLE (13107-108-05)
  • 20 TABLET in 1 BOTTLE (13107-108-20)
  • 1000 TABLET in 1 BOTTLE (13107-108-99)
source: ndc

Packages (4)

13107-108-01 100 TABLET in 1 BOTTLE (13107-108-01) 13107-108-05 500 TABLET in 1 BOTTLE (13107-108-05) 13107-108-20 20 TABLET in 1 BOTTLE (13107-108-20) 13107-108-99 1000 TABLET in 1 BOTTLE (13107-108-99)

Ingredients (1)

hydromorphone hydrochloride (4 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": "1c45740c-5fb6-4cf7-81b9-0865717334e5", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897696", "897702", "897710"], "spl_set_id": ["f778dfab-e109-428e-b1b7-4dfb1b8293e4"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-108-01)", "package_ndc": "13107-108-01", "marketing_start_date": "20160517"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13107-108-05)", "package_ndc": "13107-108-05", "marketing_start_date": "20160517"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (13107-108-20)", "package_ndc": "13107-108-20", "marketing_start_date": "20160517"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-108-99)", "package_ndc": "13107-108-99", "marketing_start_date": "20160517"}], "brand_name": "HYDROMORPHONE HYDROCHLORIDE", "product_id": "13107-108_1c45740c-5fb6-4cf7-81b9-0865717334e5", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-108", "dea_schedule": "CII", "generic_name": "HYDROMORPHONE HYDROCHLORIDE", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROMORPHONE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA205814", "marketing_category": "ANDA", "marketing_start_date": "20160517", "listing_expiration_date": "20261231"}