hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: trigen laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydromorphone hydrochloride 16 mg/1

Manufacturer
Trigen Laboratories, LLC

Identifiers & Regulatory

Product NDC 13811-703
Product ID 13811-703_e22a1e07-ff84-4ef1-b154-804b49dcd52f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205629
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-09-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13811703
Hyphenated Format 13811-703

Supplemental Identifiers

RxCUI
902729 902736 902741 1306898 2706360
UPC
0313811701104 0313811703108 0313811704105 0313811702101
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 ANDA205629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 16 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-703-10)
source: ndc

Packages (1)

13811-703-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-703-10)

Ingredients (1)

hydromorphone hydrochloride (16 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": "e22a1e07-ff84-4ef1-b154-804b49dcd52f", "openfda": {"upc": ["0313811701104", "0313811703108", "0313811704105", "0313811702101"], "unii": ["L960UP2KRW"], "rxcui": ["902729", "902736", "902741", "1306898", "2706360"], "spl_set_id": ["8bb81796-6990-40e9-bee4-1f292f91ae99"], "manufacturer_name": ["Trigen Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-703-10)", "package_ndc": "13811-703-10", "marketing_start_date": "20160915"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "13811-703_e22a1e07-ff84-4ef1-b154-804b49dcd52f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13811-703", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "Trigen Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "16 mg/1"}], "application_number": "ANDA205629", "marketing_category": "ANDA", "marketing_start_date": "20160915", "listing_expiration_date": "20261231"}