NDC 55494-100 Diclegis
Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 55494 - Duchesnay Usa, Inc.
- 55494-100 - Diclegis
Product Characteristics
Product Packages
NDC Code 55494-100-10
Package Description: 100 TABLET, DELAYED RELEASE in 1 BOTTLE
Price per Unit: $3.12975 per EA
NDC Code 55494-100-99
Package Description: 12 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Details
What is NDC 55494-100?
What are the uses for Diclegis?
What are Diclegis Active Ingredients?
- DOXYLAMINE SUCCINATE 10 mg/1
- PYRIDOXINE HYDROCHLORIDE 10 mg/1 - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
Which are Diclegis UNII Codes?
The UNII codes for the active ingredients in this product are:
- DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2)
- DOXYLAMINE (UNII: 95QB77JKPL) (Active Moiety)
- PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
- PYRIDOXINE (UNII: KV2JZ1BI6Z) (Active Moiety)
Which are Diclegis 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)
- BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- D&C RED NO. 27 (UNII: 2LRS185U6K)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- ISOPROPYL ALCOHOL (UNII: ND2M416302)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MAGNESIUM TRISILICATE (UNII: C2E1CI501T)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- CARNAUBA WAX (UNII: R12CBM0EIZ)
- ALCOHOL (UNII: 3K9958V90M)
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
- SHELLAC (UNII: 46N107B71O)
- DIMETHICONE (UNII: 92RU3N3Y1O)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
What is the NDC to RxNorm Crosswalk for Diclegis?
- RxCUI: 1375948 - doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet
- RxCUI: 1375948 - doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet
- RxCUI: 1375948 - doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet
- RxCUI: 1375948 - doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet
- RxCUI: 1375954 - Diclegis 10 MG / 10 MG Delayed Release Oral Tablet
Which are the Pharmacologic Classes for Diclegis?
* Please review the disclaimer below.
Patient Education
Doxylamine and Pyridoxine
The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women whose symptoms have not improved after changing their diet or using other non-medicine treatments. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of certain natural substances in the body that may contribute to nausea and vomiting. Pyridoxine (vitamin B6) is a vitamin. It is given because a lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.
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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".