hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: ascent pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler ascent pharmaceuticals inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydromorphone hydrochloride 5 mg/5mL

Manufacturer
Ascent Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 43602-001
Product ID 43602-001_988ded2c-ad19-48a1-a623-0f9ee982c5af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210176
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-05-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43602001
Hyphenated Format 43602-001

Supplemental Identifiers

RxCUI
897657
UPC
0343602279475
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 ANDA210176 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (43602-001-47)
source: ndc

Packages (1)

43602-001-47 473 mL in 1 BOTTLE (43602-001-47)

Ingredients (1)

hydromorphone hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Hydromorphone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "988ded2c-ad19-48a1-a623-0f9ee982c5af", "openfda": {"upc": ["0343602279475"], "unii": ["L960UP2KRW"], "rxcui": ["897657"], "spl_set_id": ["e8fd7b0e-22b9-4f8a-8eb2-41d5031779af"], "manufacturer_name": ["Ascent Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (43602-001-47)", "package_ndc": "43602-001-47", "marketing_start_date": "20190504"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "43602-001_988ded2c-ad19-48a1-a623-0f9ee982c5af", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "43602-001", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "Ascent Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA210176", "marketing_category": "ANDA", "marketing_start_date": "20190504", "listing_expiration_date": "20261231"}