infumorph 500

Generic: morphine sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name infumorph 500
Generic Name morphine sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INTRATHECAL
Active Ingredients

morphine sulfate 25 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6040
Product ID 0641-6040_b1c060cb-5c5b-495f-90b5-044e04f2a3f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018565
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 1984-09-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416040
Hyphenated Format 0641-6040

Supplemental Identifiers

RxCUI
892652 1731522 1731998 1731999
UNII
X3P646A2J0

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 infumorph 500 (source: ndc)
Generic Name morphine sulfate (source: ndc)
Application Number NDA018565 (source: ndc)
Routes
EPIDURAL INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 20 mL in 1 AMPULE (0641-6040-01)
source: ndc

Packages (1)

0641-6040-01 20 mL in 1 AMPULE (0641-6040-01)

Ingredients (1)

morphine sulfate (25 mg/mL)

Linked Drug Pages (1)

INFUMORPH 200, INFUMORPH 500 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRATHECAL"], "spl_id": "b1c060cb-5c5b-495f-90b5-044e04f2a3f2", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["892652", "1731522", "1731998", "1731999"], "spl_set_id": ["db9ac9e3-d761-4a99-9f34-4946ebe8f255"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 AMPULE (0641-6040-01)", "package_ndc": "0641-6040-01", "marketing_start_date": "19840918"}], "brand_name": "INFUMORPH 500", "product_id": "0641-6040_b1c060cb-5c5b-495f-90b5-044e04f2a3f2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6040", "dea_schedule": "CII", "generic_name": "morphine sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INFUMORPH 500", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "25 mg/mL"}], "application_number": "NDA018565", "marketing_category": "NDA", "marketing_start_date": "19840918", "listing_expiration_date": "20271231"}