NDC 68462-446 Sevelamer Hydrochloride

Sevelamer Hydrochloride

NDC Product Code 68462-446

NDC Code: 68462-446

Proprietary Name: Sevelamer Hydrochloride Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Sevelamer Hydrochloride Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
WHITE (C48325 - OFF-WHITE TO PALE YELLOW)
Shape: OVAL (C48345)
Size(s):
15 MM
Imprint(s):
G446
Score: 1

Code Structure
  • 68462 - Glenmark Pharmaceuticals Inc., Usa
    • 68462-446 - Sevelamer Hydrochloride

NDC 68462-446-26

Package Description: 360 TABLET, FILM COATED in 1 BOTTLE

NDC 68462-446-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Sevelamer Hydrochloride with NDC 68462-446 is a a human prescription drug product labeled by Glenmark Pharmaceuticals Inc., Usa. The generic name of Sevelamer Hydrochloride is sevelamer hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Glenmark Pharmaceuticals Inc., Usa

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat 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.


Sevelamer Hydrochloride Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SEVELAMER HYDROCHLORIDE 400 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MANNITOL (UNII: 3OWL53L36A)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • AMMONIA (UNII: 5138Q19F1X)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SHELLAC (UNII: 46N107B71O)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glenmark Pharmaceuticals Inc., Usa
Labeler Code: 68462
FDA Application Number: ANDA204724 Additional informationCallout TooltipWhat 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat 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.

Start Marketing Date: 02-08-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sevelamer Hydrochloride Product Label Images