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 76045-008
Product ID 76045-008_286bce70-23cd-4d5b-989b-230d6cdd5a91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204223
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-10-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045008
Hyphenated Format 76045-008

Supplemental Identifiers

RxCUI
894912 894914 998212 998213 1442790
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
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Morphine Sulfate Injection, USP is available for intravenous (IV) or intramuscular (IM) use as: Product Code Unit of Sale Strength Each 764411 NDC 76045-004-11 Unit of 10 2 mg/mL NDC 76045-004-01 1 mL single-dose prefilled syringe 764511 NDC 76045-005-11 Unit of 10 4 mg/mL NDC 76045-005-01 1 mL single-dose prefilled syringe Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. DO NOT FREEZE.
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Morphine 1 mL Carton Panel Rx only 764411 NDC 76045-004-11 Morphine Sulfate Injection, USP CII 2 mg/mL For Intramuscular or Intravenous use. Do NOT dilute for IV push. Do NOT place syringe on a Sterile Field. 10 x 1 mL single-dose prefilled syringes Discard unused portion morph-label-01.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Morphine 1 mL Tip Cap Label Morphine Sulfate Injection, USP CII 2 mg/mL For IM or IV use ONLY. morph-label-02.jpg
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Morphine 1 mL Syringe Label For IM or IV use. 1mL Single-Dose. Morphine Sulfate Injection, USP CII 2 mg/mL Rx only morph-label-03.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Morphine 1 mL Carton Panel Rx only 764511 NDC 76045-005-11 Morphine Sulfate Injection, USP CII 4 mg/mL For Intramuscular or Intravenous use. Do NOT dilute for IV push. Do NOT place syringe on a Sterile Field. 10 x 1 mL single-dose prefilled syringes Discard unused portion. morph-label-04.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY – Morphine 1 mL Tip Cap Label Morphine Sulfate Injection, USP CII 4 mg/mL For IM or IV use ONLY. morph-label-05.jpg
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Morphine 1 mL Syringe Label For IM or IV use. 1mL Single-Dose. Morphine Sulfate Injection, USP CII 4 mg/mL Rx only morph-label-06.jpg
source: label

Packages (0)

No package records.

Ingredients (1)

morphine sulfate (10 mg/mL)

Linked Drug Pages (2)

Morphine Sulfate ndc-match (0.9) Morphine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "286bce70-23cd-4d5b-989b-230d6cdd5a91", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["894912", "894914", "998212", "998213", "1442790"], "spl_set_id": ["1f53de80-efc8-4930-b3e3-fba0d026af05"], "manufacturer_name": ["Fresenius Kabi, USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Morphine Sulfate", "product_id": "76045-008_286bce70-23cd-4d5b-989b-230d6cdd5a91", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76045-008", "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": "20131030", "listing_expiration_date": "20261231"}