NDC 0378-6333 Acamprosate Calcium
Acamprosate Calcium Enteric-coated Tablet, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0378 - Mylan Pharmaceuticals Inc.
- 0378-6333 - Acamprosate Calcium
Product Characteristics
Product Packages
NDC Code 0378-6333-80
Package Description: 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Price per Unit: $0.51920 per EA
Product Details
What is NDC 0378-6333?
What are the uses for Acamprosate Calcium?
What are Acamprosate Calcium Active Ingredients?
- ACAMPROSATE CALCIUM 333 mg/1 - Structural analog of taurine that is used for the prevention of relapse in individuals with ALCOHOLISM.
Which are Acamprosate Calcium UNII Codes?
The UNII codes for the active ingredients in this product are:
- ACAMPROSATE CALCIUM (UNII: 59375N1D0U)
- ACAMPROSATE (UNII: N4K14YGM3J) (Active Moiety)
Which are Acamprosate Calcium Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- AMMONIA (UNII: 5138Q19F1X)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- TALC (UNII: 7SEV7J4R1U)
What is the NDC to RxNorm Crosswalk for Acamprosate Calcium?
- RxCUI: 835726 - acamprosate calcium 333 MG Delayed Release Oral Tablet
- RxCUI: 835726 - acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet
* Please review the disclaimer below.
Patient Education
Acamprosate
Acamprosate is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol (alcoholism) to avoid drinking alcohol again. Drinking alcohol for a long time changes the way the brain works. Acamprosate works by helping the brains of people who have drunk large amounts of alcohol to work normally again. Acamprosate does not prevent the withdrawal symptoms that people may experience when they stop drinking alcohol. Acamprosate has not been shown to work in people who have not stopped drinking alcohol or in people who drink large amounts of alcohol and also overuse or abuse other substances such as street drugs or prescription medications.
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* Please review the disclaimer below.
[1] 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.
[2] 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".