Sodium Bicarbonate
Aphena Pharma Solutions - Tennessee, Llc
Human Otc Drug
NDC 43353-041Sodium Bicarbonate is a human otc drug labeled by 'Aphena Pharma Solutions - Tennessee, Llc'. National Drug Code (NDC) number for Sodium Bicarbonate is 43353-041. This drug is available in dosage form of Tablet, Orally Disintegrating. The names of the active, medicinal ingredients in Sodium Bicarbonate drug includes Sodium Bicarbonate - 650 mg/1 . The currest status of Sodium Bicarbonate drug is Active.
Drug Information:
| Drug NDC: | 43353-041 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sodium Bicarbonate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Bicarbonate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aphena Pharma Solutions - Tennessee, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Orally Disintegrating |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM BICARBONATE - 650 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 26 Jun, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part331 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Aphena Pharma Solutions - Tennessee, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | 8MDF5V39QO
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 43353-041-53 | 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-53) | 14 Jul, 2015 | N/A | No |
| 43353-041-60 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-60) | 17 May, 2015 | N/A | No |
| 43353-041-70 | 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-70) | 16 Jun, 2015 | N/A | No |
| 43353-041-80 | 180 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-80) | 05 Jun, 2015 | N/A | No |
| 43353-041-85 | 200 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-85) | 06 Jun, 2015 | N/A | No |
| 43353-041-94 | 360 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-94) | 30 Jul, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Indications: relieves ⢠acid indigestion ⢠heartburn ⢠sour stomach ⢠upset stomach associated with these symptoms
Product Elements:
Sodium bicarbonate sodium bicarbonate sodium bicarbonate bicarbonate ion starch, corn mineral oil cl;206
Indications and Usage:
Warnings:
Warnings do not use this product if you are on a sodium-restricted diet unless directed by a doctor. do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. as with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.
Dosage and Administration:
Directions: adults -take 1 tablet, dissolved in a glass of water, as needed. ⢠maximum daily dose for adults up to 60 years of age is 24 tablets. ⢠maximum daily dose for adults 60 years of age or older is 12 tablets. ⢠dissolve completely in water before drinking. ⢠do not exceed recommended dose. not recommended for children.
Package Label Principal Display Panel:
Principal display panel ndc 43353-041-53 sodium bicarbonate antacid 60 tablets principal display panel - 60 tablets