morphine sulfate

Generic: morphine sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

morphine sulfate 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-451
Product ID 63323-451_dbf870e7-7bfe-48f0-ba6a-9cc476dfe5cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204223
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-04-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323451
Hyphenated Format 63323-451

Supplemental Identifiers

RxCUI
1731993 1732006 1732011 1732136 2003714
UPC
0363323454005 0363323451004
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 NDA204223 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 BOX (63323-451-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-451-00)
source: ndc

Packages (1)

63323-451-01 25 VIAL, SINGLE-DOSE in 1 BOX (63323-451-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-451-00)

Ingredients (1)

morphine sulfate (10 mg/mL)

Linked Drug Pages (1)

Morphine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "dbf870e7-7bfe-48f0-ba6a-9cc476dfe5cc", "openfda": {"upc": ["0363323454005", "0363323451004"], "unii": ["X3P646A2J0"], "rxcui": ["1731993", "1732006", "1732011", "1732136", "2003714"], "spl_set_id": ["582f42e5-444e-4246-af8c-e7e28097c69a"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 BOX (63323-451-01)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-451-00)", "package_ndc": "63323-451-01", "marketing_start_date": "20180410"}], "brand_name": "Morphine Sulfate", "product_id": "63323-451_dbf870e7-7bfe-48f0-ba6a-9cc476dfe5cc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63323-451", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "10 mg/mL"}], "application_number": "NDA204223", "marketing_category": "NDA", "marketing_start_date": "20180410", "listing_expiration_date": "20261231"}