morphine sulfate

Generic: morphine sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

morphine sulfate 4 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6192
Product ID 0641-6192_cbc693d6-fa17-4710-b91f-22c4f5d74793
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211452
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-04-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416192
Hyphenated Format 0641-6192

Supplemental Identifiers

RxCUI
998212 998213
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 ANDA211452 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 PACKAGE (0641-6192-10) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

0641-6192-10 10 SYRINGE in 1 PACKAGE (0641-6192-10) / 1 mL in 1 SYRINGE

Ingredients (1)

morphine sulfate (4 mg/mL)

Linked Drug Pages (1)

Morphine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "cbc693d6-fa17-4710-b91f-22c4f5d74793", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["998212", "998213"], "spl_set_id": ["69a0d5be-3211-4b7f-962b-e9d9a507321f"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 PACKAGE (0641-6192-10)  / 1 mL in 1 SYRINGE", "package_ndc": "0641-6192-10", "marketing_start_date": "20250418"}], "brand_name": "Morphine Sulfate", "product_id": "0641-6192_cbc693d6-fa17-4710-b91f-22c4f5d74793", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6192", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "4 mg/mL"}], "application_number": "ANDA211452", "marketing_category": "ANDA", "marketing_start_date": "20250418", "listing_expiration_date": "20261231"}