The NDC Code 0135-0569-01 is assigned to a package of 32 bar, chewable in 1 bag of Tums Chewy Delights, a human over the counter drug labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is bar, chewable and is administered via oral form.
||32 BAR, CHEWABLE in 1 BAG
||Tums Chewy Delights 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.
||Calcium Carbonate 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.
||This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
|11-Digit NDC Billing Format
||00135056901 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
||EA - Billing unit of "each" is used when the product is dispensed in discreet units.
||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.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
||Bar, Chewable - A solid dosage form usually in the form of a rectangle that is meant to be chewed.
- Oral - Administration to or by way of the mouth.
- CALCIUM CARBONATE 1177 mg/1
||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
||OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.
|FDA Application Number
||part331 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.
|Start Marketing Date
||08-15-2014 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
||12-31-2022 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.
||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 ("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".
NDC Code Structure
- 0135 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc
- 0135-0569 - Tums
0135-0569-01 - 32 BAR, CHEWABLE in 1 BAG
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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