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NDC 70369-0001-08 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 CitraGen Pharmaceuticals Inc.. 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: 70369-0001-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
| NDC | 70369-0001 |
|---|---|
| Product ID | 70369-001_a9025118-be54-ebc4-e053-2995a90a9af9 |
| 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 | 10 gr (650 mg) |
| 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 | CitraGen Pharmaceuticals Inc. |
| 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 70369-0001-08 (70369000108)
| NDC Package Code | 70369-001-08 |
|---|---|
| Billing NDC | 70369000108 |
| Package | 120 TABLET in 1 BOTTLE (70369-001-08) |
| Marketing Start Date | 2020-06-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 650fa284-5829-588f-e053-2991aa0a9a0e Details
Warnings
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 the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
Directions
- do not use the maximum dosage for more than 2 weeks
- tablets may be swallowed whole or dissolved in water prior to use
- adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
- adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
Other information
Questions or comments?
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| SODIUM BICARBONATE
10 GR (650 MG)
sodium bicarbonate tablet |
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| Labeler - CitraGen Pharmaceuticals Inc. (024949457) |
| Registrant - CitraGen Pharmaceuticals Inc. (024949457) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| CitraGen Pharmaceuticals Inc | 024949457 | manufacture(70369-001) | |
Revised: 6/2020
Document Id: a9025118-be54-ebc4-e053-2995a90a9af9
Set id: 650fa284-5829-588f-e053-2991aa0a9a0e
Version: 3
Effective Time: 20200626