NDC 52682-206 Sodium Bicarbonate

Sodium Bicarbonate

NDC Product Code 52682-206

NDC CODE: 52682-206

Proprietary Name: Sodium Bicarbonate 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: Sodium Bicarbonate 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.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
CL;206
Score: 2

NDC Code Structure

  • 52682 - Ingenus Pharmaceuticals Nj, Llc

NDC 52682-206-04

Package Description: 1000 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Sodium Bicarbonate with NDC 52682-206 is a a human over the counter drug product labeled by Ingenus Pharmaceuticals Nj, Llc. The generic name of Sodium Bicarbonate is sodium bicarbonate. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 198861.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Sodium Bicarbonate 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.


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.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: Ingenus Pharmaceuticals Nj, Llc
Labeler Code: 52682
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.

Marketing Category: 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.

Start Marketing Date: 01-24-2011 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Information for Patients

Sodium Bicarbonate

Sodium Bicarbonate is pronounced as (soe' dee um) (bye kar' bon ate)

Why is sodium bicarbonate medication prescribed?
Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic...
[Read More]

* Please review the disclaimer below.

Sodium Bicarbonate 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

Drug Facts

Active Ingredient (in each tablet)Sodium bicarbonate 10 gr (650 mg)

Indications:

  • Relieves:acid indigestionheartburnsour stomachupset stomachassociated with these symptoms

Stomach Warning:

TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

Drug Interaction Precaution:

Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

Directions:

  • Adults - Take 1 tablet, dissolved in a glass of water, as needed.Maximum daily dose for adults upto 60 years of age is 24 tablets.Maximum daily dose for adults 60 years of age and older is 12 tablets.Dissolve completely in water before drinking.DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information:

  • Each tablet contains: sodium 178 mg (7.74 meq)store at room temperature 15°- 30°C (59°- 86°F) in well-closed containers as defined in the USP.

Inactive Ingredients:

Pregelatinized starch, NF and mieral oil, USP.

* Please review the disclaimer below.