NDC 55545-1007 Dorzolamide And Timolol

NDC Product Code 55545-1007

NDC 55545-1007-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 5 mL in 1 BOTTLE, PLASTIC

NDC 55545-1007-2

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 10 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

NDC Product Information

Dorzolamide And Timolol with NDC 55545-1007 is a product labeled by Fdc Limited. The generic name of Dorzolamide And Timolol is . The product's dosage form is and is administered via form.

Labeler Name: Fdc Limited

Dosage Form: -

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.

Inactive Ingredient(s)

About 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.

  • MANNITOL (UNII: 3OWL53L36A)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
  • HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Fdc Limited
Labeler Code: 55545
Start Marketing Date: 11-16-2019 What 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 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.

Exclude Flag: Y 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dorzolamide And Timolol Product Label Images