morphine sulfate

Generic: morphine sulfate

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

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

morphine sulfate 100 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0517
Product ID 0054-0517_ef95fffb-fc3a-45db-8570-5ae639369199
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022195
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2008-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540517
Hyphenated Format 0054-0517

Supplemental Identifiers

RxCUI
892589 892625 894780
UPC
0300540238636 0300540237493
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 morphine sulfate (source: ndc)
Generic Name morphine sulfate (source: ndc)
Application Number NDA022195 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (0054-0517-41)
  • 30 mL in 1 BOTTLE (0054-0517-44)
  • 120 mL in 1 BOTTLE (0054-0517-50)
source: ndc

Packages (3)

0054-0517-41 15 mL in 1 BOTTLE (0054-0517-41) 0054-0517-44 30 mL in 1 BOTTLE (0054-0517-44) 0054-0517-50 120 mL in 1 BOTTLE (0054-0517-50)

Ingredients (1)

morphine sulfate (100 mg/5mL)

Linked Drug Pages (1)

Morphine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef95fffb-fc3a-45db-8570-5ae639369199", "openfda": {"upc": ["0300540238636", "0300540237493"], "unii": ["X3P646A2J0"], "rxcui": ["892589", "892625", "894780"], "spl_set_id": ["ca359246-4674-4b32-b8b2-673d32b7112f"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (0054-0517-41)", "package_ndc": "0054-0517-41", "marketing_start_date": "20150810"}, {"sample": false, "description": "30 mL in 1 BOTTLE (0054-0517-44)", "package_ndc": "0054-0517-44", "marketing_start_date": "20150810"}, {"sample": false, "description": "120 mL in 1 BOTTLE (0054-0517-50)", "package_ndc": "0054-0517-50", "marketing_start_date": "20150810"}], "brand_name": "Morphine Sulfate", "product_id": "0054-0517_ef95fffb-fc3a-45db-8570-5ae639369199", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0517", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "100 mg/5mL"}], "application_number": "NDA022195", "marketing_category": "NDA", "marketing_start_date": "20080317", "listing_expiration_date": "20261231"}