hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: teva parenteral medicines, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler teva parenteral medicines, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

hydromorphone hydrochloride 10 mg/mL

Manufacturer
Teva Parenteral Medicines, Inc.

Identifiers & Regulatory

Product NDC 0703-0110
Product ID 0703-0110_c32108cc-7b73-4921-9f9e-54b3d60c1c6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078591
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2011-01-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07030110
Hyphenated Format 0703-0110

Supplemental Identifiers

RxCUI
1724338 1724340 1724341
UPC
0307030110038
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 ANDA078591 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0703-0110-03) / 1 mL in 1 VIAL (0703-0110-01)
source: ndc

Packages (1)

0703-0110-03 10 VIAL in 1 CARTON (0703-0110-03) / 1 mL in 1 VIAL (0703-0110-01)

Ingredients (1)

hydromorphone hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Hydromorphone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "c32108cc-7b73-4921-9f9e-54b3d60c1c6e", "openfda": {"upc": ["0307030110038"], "unii": ["L960UP2KRW"], "rxcui": ["1724338", "1724340", "1724341"], "spl_set_id": ["f0b78db9-a38c-41bb-8233-5e93f7f18c5c"], "manufacturer_name": ["Teva Parenteral Medicines, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0703-0110-03)  / 1 mL in 1 VIAL (0703-0110-01)", "package_ndc": "0703-0110-03", "marketing_start_date": "20110118"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0703-0110_c32108cc-7b73-4921-9f9e-54b3d60c1c6e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0703-0110", "dea_schedule": "CII", "generic_name": "HYDROMORPHONE HYDROCHLORIDE", "labeler_name": "Teva Parenteral Medicines, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA078591", "marketing_category": "ANDA", "marketing_start_date": "20110118", "listing_expiration_date": "20261231"}