hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler xlcare pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

hydromorphone hydrochloride 32 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-171
Product ID 72865-171_55fb6272-5677-43cf-b92d-5a6a6f484b6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212133
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-09-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865171
Hyphenated Format 72865-171

Supplemental Identifiers

RxCUI
902729 902736 902741 1306898
UPC
0372865168011 0372865171011 0372865170014 0372865169018
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 ANDA212133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 32 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-171-01)
source: ndc

Packages (1)

72865-171-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-171-01)

Ingredients (1)

hydromorphone hydrochloride (32 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": "55fb6272-5677-43cf-b92d-5a6a6f484b6e", "openfda": {"upc": ["0372865168011", "0372865171011", "0372865170014", "0372865169018"], "unii": ["L960UP2KRW"], "rxcui": ["902729", "902736", "902741", "1306898"], "spl_set_id": ["90bda45c-9dbe-4ed5-91d0-df8446ad7026"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-171-01)", "package_ndc": "72865-171-01", "marketing_start_date": "20200924"}], "brand_name": "hydromorphone hydrochloride", "product_id": "72865-171_55fb6272-5677-43cf-b92d-5a6a6f484b6e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72865-171", "dea_schedule": "CII", "generic_name": "hydromorphone hydrochloride", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydromorphone hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "32 mg/1"}], "application_number": "ANDA212133", "marketing_category": "ANDA", "marketing_start_date": "20200924", "listing_expiration_date": "20261231"}