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 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-455
Product ID 63323-455_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 63323455
Hyphenated Format 63323-455

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
  • 5 mg/mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Morphine Sulfate Injection, USP is supplied as a sterile solution in single dose vials for intravenous (IV) or intramuscular (IM) use as follows: Product Code Unit of Sale Strength Each 475201 NDC 63323-452-01 Unit of 25 2 mg per mL NDC 63323-452-00 1 mL Single Dose Vial 475401 NDC 63323-454-01 Unit of 25 4 mg per mL NDC 63323-454-00 1 mL Single Dose Vial 475101 NDC 63323-451-01 Unit of 25 10 mg per mL NDC 63323-451-00 1 mL Single Dose Vial STORE AT: 20° C to 25° C (68° F to 77° F ) [see USP Controlled Room Temperature]. Protect from light (keep in outer carton). Discard unused portion. Keep from freezing. Do not autoclave. Contains no preservative or antioxidant. The container closure is not made with natural rubber latex.
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Morphine Sulfate 1 mL Single Dose Vial Label NDC 63323-451-00 475101 Morphine Sulfate Injection, USP CII 10 mg per mL For IV or IM use only. Preservative free. Protect from light (keep in outer carton). Keep from freezing. 1 mL Single Dose Vial Rx only morph-label-01.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Morphine Sulfate 1 mL Single Dose Vial Tray Label NDC 63323-451-01 475101 Morphine Sulfate Injection, USP CII 10 mg per mL For intravenous or intramuscular use only. Preservative free. Rx only 25 x 1 mL Single Dose Vials morph-label-02.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Morphine Sulfate 1 mL Single Dose Vial Label NDC 63323-452-00 475201 Morphine Sulfate Injection, USP CII 2 mg per mL For IV or IM use only. Preservative free. Protect from light (keep in outer carton). Keep from freezing. 1 mL Single Dose Vial Rx only morph-label-03.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Morphine Sulfate 1 mL Single Dose Vial Tray Label NDC 63323-452-01 475201 Morphine Sulfate Injection, USP CII 2 mg per mL For intravenous or intramuscular use only. Preservative free. Rx only 25 x 1 mL Single Dose Vials morph-label-04.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Morphine Sulfate 1 mL Single Dose Vial Label NDC 63323-454-00 475401 Morphine Sulfate Injection, USP CII 4 mg per mL For IV or IM use only. Preservative free. Protect from light (keep in outer carton). Keep from freezing. 1 mL Single Dose Vial Rx only morph-label-05.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Morphine Sulfate 1 mL Single Dose Vial Tray Label NDC 63323-454-01 475401 Morphine Sulfate Injection, USP CII 4 mg per mL For intravenous or intramuscular use only. Preservative free. Rx only 25 x 1 mL Single Dose Vials morph-label-06.jpg
source: label

Packages (0)

No package records.

Ingredients (1)

morphine sulfate (5 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": [], "brand_name": "Morphine Sulfate", "product_id": "63323-455_dbf870e7-7bfe-48f0-ba6a-9cc476dfe5cc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63323-455", "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": "5 mg/mL"}], "application_number": "NDA204223", "marketing_category": "NDA", "marketing_start_date": "20180410", "listing_expiration_date": "20261231"}