hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler asclemed usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydromorphone hydrochloride 2 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 87063-037
Product ID 87063-037_451ccd08-4749-97a1-e063-6294a90ac5ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019892
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2009-11-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 87063037
Hyphenated Format 87063-037

Supplemental Identifiers

RxCUI
897696 897702 897710
UNII
L960UP2KRW

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 NDA019892 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (87063-037-01)
  • 5 TABLET in 1 BOTTLE, PLASTIC (87063-037-05)
  • 7 TABLET in 1 BOTTLE, PLASTIC (87063-037-07)
  • 10 TABLET in 1 BOTTLE, PLASTIC (87063-037-10)
  • 14 TABLET in 1 BOTTLE, PLASTIC (87063-037-14)
  • 20 TABLET in 1 BOTTLE, PLASTIC (87063-037-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (87063-037-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (87063-037-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (87063-037-90)
source: ndc

Packages (9)

87063-037-01 100 TABLET in 1 BOTTLE, PLASTIC (87063-037-01) 87063-037-05 5 TABLET in 1 BOTTLE, PLASTIC (87063-037-05) 87063-037-07 7 TABLET in 1 BOTTLE, PLASTIC (87063-037-07) 87063-037-10 10 TABLET in 1 BOTTLE, PLASTIC (87063-037-10) 87063-037-14 14 TABLET in 1 BOTTLE, PLASTIC (87063-037-14) 87063-037-20 20 TABLET in 1 BOTTLE, PLASTIC (87063-037-20) 87063-037-30 30 TABLET in 1 BOTTLE, PLASTIC (87063-037-30) 87063-037-60 60 TABLET in 1 BOTTLE, PLASTIC (87063-037-60) 87063-037-90 90 TABLET in 1 BOTTLE, PLASTIC (87063-037-90)

Ingredients (1)

hydromorphone hydrochloride (2 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": "451ccd08-4749-97a1-e063-6294a90ac5ad", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897696", "897702", "897710"], "spl_set_id": ["18f6f54e-1537-4181-9d07-54ddf881a9ee"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (87063-037-01)", "package_ndc": "87063-037-01", "marketing_start_date": "20251204"}, {"sample": false, "description": "5 TABLET in 1 BOTTLE, PLASTIC (87063-037-05)", "package_ndc": "87063-037-05", "marketing_start_date": "20251204"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE, PLASTIC (87063-037-07)", "package_ndc": "87063-037-07", "marketing_start_date": "20251204"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (87063-037-10)", "package_ndc": "87063-037-10", "marketing_start_date": "20251204"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (87063-037-14)", "package_ndc": "87063-037-14", "marketing_start_date": "20251204"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (87063-037-20)", "package_ndc": "87063-037-20", "marketing_start_date": "20251204"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (87063-037-30)", "package_ndc": "87063-037-30", "marketing_start_date": "20251204"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (87063-037-60)", "package_ndc": "87063-037-60", "marketing_start_date": "20251204"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (87063-037-90)", "package_ndc": "87063-037-90", "marketing_start_date": "20251204"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "87063-037_451ccd08-4749-97a1-e063-6294a90ac5ad", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "87063-037", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "NDA019892", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20091123", "listing_expiration_date": "20261231"}