NDC 64543-118 Symax Duotab
Hyoscyamine Sulfate Tablet, Multilayer, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 64543 - Capellon Pharmaceuticals, Llc
- 64543-118 - Symax Duotab
Product Characteristics
PURPLE (C48327 - LAYER 1)
Product Packages
NDC Code 64543-118-02
Package Description: 12 POUCH in 1 CARTON / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 POUCH
NDC Code 64543-118-90
Package Description: 90 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Product Details
What is NDC 64543-118?
What are the uses for Symax Duotab?
What are Symax Duotab Active Ingredients?
Which are Symax Duotab UNII Codes?
The UNII codes for the active ingredients in this product are:
- HYOSCYAMINE SULFATE (UNII: F2R8V82B84)
- HYOSCYAMINE (UNII: PX44XO846X) (Active Moiety)
Which are Symax Duotab 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:
- CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
- D&C RED NO. 30 (UNII: 2S42T2808B)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- POVIDONE K30 (UNII: U725QWY32X)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
What is the NDC to RxNorm Crosswalk for Symax Duotab?
- RxCUI: 1807886 - hyoscyamine sulfate 0.375 MG Biphasic 12HR Extended Release Oral Tablet
- RxCUI: 1807886 - Biphasic 12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet
- RxCUI: 1807886 - hyoscyamine sulfate 0.375 MG Biphasic (0.125 MG / 0.25 MG) 12 HR Extended Release Oral Tablet
- RxCUI: 1807886 - hyoscyamine sulfate 0.375 MG Biphasic 12 HR Extended Release Oral Tablet
- RxCUI: 1807887 - Symax Duotab 0.375 MG Biphasic 12HR Extended Release Oral Tablet
* Please review the disclaimer below.
Patient Education
Hyoscyamine
Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It works by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid. Hyoscyamine is also used in the treatment of bladder spasms, peptic ulcer disease, diverticulitis, colic, irritable bowel syndrome, cystitis, and pancreatitis. Hyoscyamine may also be used to treat certain heart conditions, to control the symptoms of Parkinson's disease and rhinitis (runny nose), and to reduce excess saliva production.
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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.
[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.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[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".