NDC Compounded Drug 70004-100-16 Morphine Sulfate

Injection, Solution Intravenous

Compounded Product Information
NDC Crossover Products Matching Morphine 1 Mg/ml In 0.9% Sodium Chloride
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	70004-100
NDC Package Code	70004-100-16
11-Digit NDC Billing Format NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.	70004010016
Package Description	30 mL in 1 SYRINGE
Product Type What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.	Human Compounded Drug
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Morphine 1 Mg/ml In 0.9% Sodium Chloride
Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.	Morphine 1 Mg/ml In 0.9% Sodium Chloride
Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.	Morphine Sulfate
Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.	This medication is used to help relieve severe ongoing pain (such as due to cancer). Morphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. The higher strengths of this drug (100 milligrams per capsule and higher) should be used only if you have been regularly taking moderate to large amounts of an opioid pain medication. These strengths may cause overdose (even death) if taken by a person who has not been regularly taking opioids. Do not use the sustained-action form of morphine to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
Dosage Form	Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Route Name	Intravenous - Administration within or into a vein or veins.
Marketing Category	OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code	70004
Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Sca Pharmaceuticals, Llc
Substance Name	Morphine Sulfate
Active Ingredients Information	1 mg/1 mL
DEA Schedule What is the Drug Enforcement Administration (DEA) CII Schedule? The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs.	Schedule II (CII) Substances
Reporting Period	2021-2

NDC Crossover Products Matching Morphine Sulfate

NDC crossover of Morphine 1 Mg/ml In 0.9% Sodium Chloride with NDC 70004-100 a human compounded drug with other similar products matching the same substance name (Morphine Sulfate) and the same administration route (intravenous) or dosage form (injection, solution).

NDC	Proprietary Name	Non-Proprietary Name	Package Desc	Dosage Form	Route Name	Company Name
69374-979-01	Pf-morphine Sulfate 2 Mg/2 Ml	Pf-morphine Sulfate 2 Mg/2 Ml (1 Mg/ml)	6 CARTON in 1 CASE > 5 SYRINGE, GLASS in 1 CARTON > 1 mL in 1 SYRINGE, GLASS	Injection, Solution	Intravenous	Nephron Sterile Compounding Center, Llc
69374-979-02	Pf-morphine Sulfate 2 Mg/2 Ml	Pf-morphine Sulfate 2 Mg/2 Ml (1 Mg/ml)	6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 2 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Nephron Sterile Compounding Center, Llc
69374-979-02	Pf-morphine Sulfate 2 Mg/2 Ml	Pf-morphine Sulfate 2 Mg/2 Ml (1 Mg/ml)	6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 2 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Nephron Sterile Compounding Center, Llc
69374-979-30	Pf-morphine Sulfate 2 Mg/2 Ml	Pf-morphine Sulfate 2 Mg/2 Ml (1 Mg/ml)	6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 30 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Nephron Sterile Compounding Center, Llc
69374-979-30	Pf-morphine Sulfate 2 Mg/2 Ml	Pf-morphine Sulfate 2 Mg/2 Ml (1 Mg/ml)	6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 30 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Nephron Sterile Compounding Center, Llc
69374-979-50	Pf-morphine Sulfate 2 Mg/2 Ml	Pf-morphine Sulfate 2 Mg/2 Ml (1 Mg/ml)	6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 50 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Nephron Sterile Compounding Center, Llc
69374-979-50	Pf-morphine Sulfate 2 Mg/2 Ml	Pf-morphine Sulfate 2 Mg/2 Ml (1 Mg/ml)	6 CARTON in 1 CASE > 5 SYRINGE, PLASTIC in 1 CARTON > 50 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Nephron Sterile Compounding Center, Llc
70004-100-59	Morphine 1 Mg/ml In 0.9% Sodium Chloride	Morphine 1 Mg/ml In 0.9% Sodium Chloride	100 mL in 1 BAG	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
70004-100-62	Morphine 1 Mg/ml In 0.9% Sodium Chloride	Morphine 1 Mg/ml In 0.9% Sodium Chloride	50 mL in 1 BAG	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
70004-100-63	Morphine 1 Mg/ml In 0.9% Sodium Chloride	Morphine 1 Mg/ml In 0.9% Sodium Chloride	100 mL in 1 BAG	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
70004-103-16	Morphine 5 Mg/ml In 0.9% Sodium Chloride	Morphine 5 Mg/ml In 0.9% Sodium Chloride	30 mL in 1 SYRINGE	Injection, Solution	Intravenous	Sca Pharmaceuticals, Llc
70324-427-01	Morphine In 0.9% Sodium Chloride	Morphine	50 mL in 1 BAG	Injection, Solution	Intravenous	Sterrx Llc
70324-427-02	Morphine In 0.9% Sodium Chloride	Morphine	100 mL in 1 BAG	Injection, Solution	Intravenous	Sterrx Llc
70324-452-01	100 Mg Morphine Sulfate In 5% Dextrose	Morphine	100 mL in 1 BAG	Injection, Solution	Intravenous	Sterrx Llc
71449-022-32	Morphine Sulfate Preservative Free	Morphine Sulfate	30 mL in 1 SYRINGE, PLASTIC	Injection, Solution	Intravenous	Denver Solutions, Llc Dba Leiters Health
72907-2467-1	Morphine Sulfate	Morphine Sulfate	10 mL in 1 VIAL, SINGLE-USE	Injection, Solution	Epidural; Intramuscular; Intrathecal; Intravenous	Brookfield Medical Surgical Supply
73013-1010-1	Morphine Sulfate	Morphine Sulfate	30 mL in 1 VIAL	Injection, Solution	Intravenous	Ourpharma Llc

Frequently Asked Questions

What is the NDC number assigned to Morphine Sulfate?

Morphine Sulfate was assigned by its manufacturer with NDC product code 70004-100. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Morphine Sulfate?

The NDC package code 70004-100-16 was assigned to a 30 mL in 1 SYRINGE of morphine sulfate administered intravenous via injection, solution.

Who manufactures this product?

Morphine Sulfate is manufactured by an outsourced facility and labeled by Sca Pharmaceuticals, Llc. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 17 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Nephron Sterile Compounding Center, LLC, SCA Pharmaceuticals, LLC, SterRx LLC, Denver Solutions, LLC dba Leiters Health, Brookfield Medical Surgical Supply and OurPharma LLC with NDC product codes 69374-979-01, 69374-979-02, 69374-979-02, 69374-979-30, 69374-979-30, 69374-979-50, 69374-979-50, 70004-100-59, 70004-100-62, 70004-100-63, 70004-103-16, 70324-427-01, 70324-427-02, 70324-452-01, 71449-022-32, 72907-2467-1 and 73013-1010-1.

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