NDC 68788-7602 Ibuprofen

Ibuprofen

NDC Product Code 68788-7602

NDC 68788-7602-1

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-2

Package Description: 20 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-3

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-4

Package Description: 14 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-5

Package Description: 50 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-6

Package Description: 60 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-7

Package Description: 21 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-8

Package Description: 120 TABLET, FILM COATED in 1 BOTTLE

NDC 68788-7602-9

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Ibuprofen with NDC 68788-7602 is a a human prescription drug product labeled by Preferred Pharmaceuticals Inc.. The generic name of Ibuprofen is ibuprofen. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Preferred Pharmaceuticals Inc.

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 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.

Ibuprofen Active Ingredient(s)

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

  • IBUPROFEN 600 mg/1

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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

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

Pharmacological Class(es)

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

  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Anti-Inflammatory Agents -
  • Non-Steroidal - [CS]
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)

Product Labeler Information

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

Labeler Name: Preferred Pharmaceuticals Inc.
Labeler Code: 68788
FDA Application Number: ANDA090796 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.

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

Start Marketing Date: 02-14-2020 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: 12-31-2021 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: N 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.

Ibuprofen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Ibuprofen Tablets 400 Mg - 600 Mg- 800 Mg Medguide

Repackaged By: Preferred Pharmaceuticals Inc.

How Supplied

  • 600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side)  Bottles of 14NDC 68788-7602-4 Bottles of 20NDC 68788-7602-2 Bottles of 21NDC 68788-7602-7 Bottles of 30NDC 68788-7602-3 Bottles of 50NDC 68788-7602-5 Bottles of 60NDC 68788-7602-6 Bottles of 90NDC 68788-7602-9 Bottles of100NDC 68788-7602-1 Bottles of 120NDC 68788-7602-8Repackaged By: Preferred Pharmaceuticals Inc.

* Please review the disclaimer below.