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NDC 43353-0162-53 SODIUM BICARBONATE 650 mg/1 Details
SODIUM BICARBONATE 650 mg/1
SODIUM BICARBONATE is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is SODIUM BICARBONATE.
MedlinePlus Drug Summary
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 in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 43353-0162-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
NDC | 43353-0162 |
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Product ID | 43353-162_36d1abdc-f28b-4c0d-98ea-07718706c695 |
Associated GPIs | 48200010000325 |
GCN Sequence Number | 002661 |
GCN Sequence Number Description | sodium bicarbonate TABLET 650 MG ORAL |
HIC3 | D4B |
HIC3 Description | ANTACIDS |
GCN | 07855 |
HICL Sequence Number | 000523 |
HICL Sequence Number Description | SODIUM BICARBONATE |
Brand/Generic | Generic |
Proprietary Name | SODIUM BICARBONATE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | SODIUM BICARBONATE |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 650 |
Active Ingredient Units | mg/1 |
Substance Name | SODIUM BICARBONATE |
Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
Pharmaceutical Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part331 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 43353-0162-53 (43353016253)
NDC Package Code | 43353-162-53 |
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Billing NDC | 43353016253 |
Package | 60 TABLET in 1 BOTTLE, PLASTIC (43353-162-53) |
Marketing Start Date | 2016-03-30 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 15605a6d-6c90-47d5-9d1f-f66a3f27d5fc Details
Indications:
Warnings
Directions:
Other Information:
SPL UNCLASSIFIED SECTION
Questions or Comments
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count | 650 mg |
60 | 43353-162-53 |
90 | 43353-162-60 |
120 | 43353-162-70 |
180 | 43353-162-80 |
200 | 43353-162-85 |
360 | 43353-162-94 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20171213JH
INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE
sodium bicarbonate tablet |
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Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(43353-162) |