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 10 mg/5mL

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-001
Product ID 68094-001_37f26dc3-093a-4f05-a71d-1f0e280d20b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022195
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-02-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094001
Hyphenated Format 68094-001

Supplemental Identifiers

RxCUI
892589
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
  • 10 mg/5mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (68094-001-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-001-59)
source: ndc

Packages (1)

68094-001-62 3 TRAY in 1 CASE (68094-001-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-001-59)

Ingredients (1)

morphine sulfate (10 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": "37f26dc3-093a-4f05-a71d-1f0e280d20b7", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["892589"], "spl_set_id": ["8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc"], "manufacturer_name": ["Precision Dose Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (68094-001-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-001-59)", "package_ndc": "68094-001-62", "marketing_start_date": "20160229"}], "brand_name": "Morphine Sulfate", "product_id": "68094-001_37f26dc3-093a-4f05-a71d-1f0e280d20b7", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68094-001", "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": "10 mg/5mL"}], "application_number": "NDA022195", "marketing_category": "NDA", "marketing_start_date": "20160229", "listing_expiration_date": "20261231"}