morphine sulfate

Generic: morphine sulfate

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler precision dose, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

morphine sulfate 100 mg/5mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-045
Product ID 68094-045_cc30f742-9c62-4633-912f-a2afb4d39510
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022195
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094045
Hyphenated Format 68094-045

Supplemental Identifiers

RxCUI
892625
UNII
X3P646A2J0

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
  • 50 BAG in 1 CASE (68094-045-58) / 1 SYRINGE in 1 BAG / .5 mL in 1 SYRINGE (68094-045-01)
source: ndc

Packages (1)

68094-045-58 50 BAG in 1 CASE (68094-045-58) / 1 SYRINGE in 1 BAG / .5 mL in 1 SYRINGE (68094-045-01)

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": "cc30f742-9c62-4633-912f-a2afb4d39510", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["892625"], "spl_set_id": ["67f0ee8d-696e-4c08-9007-3df0e3988bad"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 BAG in 1 CASE (68094-045-58)  / 1 SYRINGE in 1 BAG / .5 mL in 1 SYRINGE (68094-045-01)", "package_ndc": "68094-045-58", "marketing_start_date": "20201101"}], "brand_name": "Morphine Sulfate", "product_id": "68094-045_cc30f742-9c62-4633-912f-a2afb4d39510", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68094-045", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Precision Dose, 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": "20201101", "listing_expiration_date": "20261231"}