NDC 70000-0518 12hr Allergy And Congestion Relief

Fexofenadine Hcl And Pseudoephedrine Hci

NDC Product Code 70000-0518

NDC Code: 70000-0518

Proprietary Name: 12hr Allergy And Congestion Relief What 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: Fexofenadine Hcl And Pseudoephedrine Hci 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.

NDC Code Structure

  • 70000 - Cardinal Health
    • 70000-0518 - 12hr Allergy And Congestion Relief

NDC 70000-0518-1

Package Description: 4 BLISTER PACK in 1 CARTON > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

12hr Allergy And Congestion Relief with NDC 70000-0518 is a a human over the counter drug product labeled by Cardinal Health. The generic name of 12hr Allergy And Congestion Relief is fexofenadine hcl and pseudoephedrine hci. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Cardinal Health

Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.

Product Type: Human Otc 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.

12hr Allergy And Congestion Relief 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.

  • FEXOFENADINE HYDROCHLORIDE 60 mg/1
  • PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1

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.

Product Labeler Information

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

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: ANDA076667 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: 10-08-2019 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: 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’.

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Information for Patients

Fexofenadine and Pseudoephedrine

Fexofenadine and Pseudoephedrine is pronounced as (fex oh fen' a deen) (soo doe e fed' rin)

Why is fexofenadine and pseudoephedrine medication prescribed?
The combination of fexofenadine and pseudoephedrine is used in adults and children 12 years of age and older to relieve the allergy symptoms of seasonal allergic rhinitis...
[Read More]

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12hr Allergy And Congestion Relief Product Label Images