NDC Compounded Drug 71286-2012-1 Hydromorphone Hydrochloride

Solution Epidural; Intravenous

Compounded Product Information
NDC Crossover Products Matching Hydromorphone Hcl 1mg/ml In Ns
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	71286-2012
NDC Package Code	71286-2012-1
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.	71286201201
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.	Hydromorphone Hcl 1mg/ml In Ns
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.	Hydromorphone Hcl 1mg/ml In Ns
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.	Hydromorphone Hydrochloride
Dosage Form	Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Route Name	Epidural; Intravenous -
Marketing Category	OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code	71286
Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Central Admixture Pharmacy Services, Inc.
Substance Name	Hydromorphone Hydrochloride
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 Hydromorphone Hydrochloride

NDC crossover of Hydromorphone Hcl 1mg/ml In Ns with NDC 71286-2012 a human compounded drug with other similar products matching the same substance name (Hydromorphone Hydrochloride) and the same administration route (epidural; intravenous) or dosage form (solution).

NDC	Proprietary Name	Non-Proprietary Name	Package Desc	Dosage Form	Route Name	Company Name
68985-234-91	Hydromorphone 50mg	Hydromorphone 50mg	250 mL in 1 BAG	Solution	Intravenous	Leesar Inc
71286-2010-1	Hydromorphone Hcl 0.2mg/ml In Ns	Hydromorphone Hcl 0.2mg/ml In Ns	30 mL in 1 SYRINGE	Solution	Epidural; Intravenous	Central Admixture Pharmacy Services, Inc.
71286-2010-2	Hydromorphone Hcl 0.2mg/ml In Ns	Hydromorphone Hcl 0.2mg/ml In Ns	50 mL in 1 SYRINGE	Solution	Epidural; Intravenous	Central Admixture Pharmacy Services, Inc.
71286-2010-3	Hydromorphone Hcl 0.2mg/ml In Ns	Hydromorphone Hcl 0.2mg/ml In Ns	50 mL in 1 BAG	Solution	Epidural; Intravenous	Central Admixture Pharmacy Services, Inc.
71286-2011-1	Hydromorphone Hcl 0.5mg/ml In Ns	Hydromorphone Hcl 0.5mg/ml In Ns	30 mL in 1 SYRINGE	Solution	Epidural; Intravenous	Central Admixture Pharmacy Services, Inc.
71286-2013-1	Hydromorphone Hcl 0.1mg/ml In D5w	Hydromorphone Hcl 0.1mg/ml In D5w	5 mL in 1 SYRINGE	Solution	Epidural; Intravenous	Central Admixture Pharmacy Services, Inc.
71286-2013-2	Hydromorphone Hcl 0.1mg/ml In D5w	Hydromorphone Hcl 0.1mg/ml In D5w	30 mL in 1 SYRINGE	Solution	Epidural; Intravenous	Central Admixture Pharmacy Services, Inc.

Frequently Asked Questions

What is the NDC number assigned to Hydromorphone Hcl 0.1mg/ml In D5w?

Hydromorphone Hcl 0.1mg/ml In D5w was assigned by its manufacturer with NDC product code 71286-2012. 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 Hydromorphone Hcl 0.1mg/ml In D5w?

The NDC package code 71286-2012-1 was assigned to a 30 mL in 1 SYRINGE of hydromorphone hydrochloride administered epidural; intravenous via solution.

Who manufactures this product?

Hydromorphone Hcl 0.1mg/ml In D5w is manufactured by an outsourced facility and labeled by Central Admixture Pharmacy Services, Inc.. 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 7 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by LEESAR INC and Central Admixture Pharmacy Services, Inc. with NDC product codes 68985-234-91, 71286-2010-1, 71286-2010-2, 71286-2010-3, 71286-2011-1, 71286-2013-1 and 71286-2013-2.

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