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NDC 70369-0002-01 Sodium Bicarbonate 325 mg/1 Details

Sodium Bicarbonate 325 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: 70369-0002-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate

Product Information

NDC	70369-0002
Product ID	70369-002_b7c04e09-4756-2129-e053-2995a90a09f7
Associated GPIs	48200010000310
GCN Sequence Number	002659
GCN Sequence Number Description	sodium bicarbonate TABLET 325 MG ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	07852
HICL Sequence Number	000523
HICL Sequence Number Description	SODIUM BICARBONATE
Brand/Generic	Generic
Proprietary Name	Sodium Bicarbonate
Proprietary Name Suffix	5 gr (325 mg)
Non-Proprietary Name	Sodium Bicarbonate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	325
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 70369-0002-01 (70369000201)

Pricing Information	N/A
NDC Package Code	70369-002-01
Billing NDC	70369000201
Package	1000 TABLET in 1 BOTTLE (70369-002-01)
Marketing Start Date	2018-04-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 68aadbd9-f1c6-8a23-e053-2991aa0afd96 Details

Drug Facts

Active ingredient (in each tablet)

Sodium Bicarbonate 5 gr (325 mg)

Purpose

Antacid

Uses

relieves:

acid indigestion

heartburn

sour stomach

upset stomach associated with these symptoms

Warnings

Do not take more than 48 tablets for adults up to 60 years of age (or 24 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.

Ask a doctor before use if you have a sodium restricted diet.

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours
adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours

Other information

each tablet contains: sodium 89 mg

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

Questions or comments?

Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: [email protected]

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

CitraGen Pharmaceuticals, Inc.,

Fremont, CA 94538.

www.citragenpharma.com

Rev. 03/18 R-00

PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369-002-01

Sodium Bicarbonate Tablets, USP 5 gr (325 mg)

ANTACID

1000 Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE 5 GR (325 MG)

sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70369-002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	325 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	CG002
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70369-002-01	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	04/20/2018

Labeler - CitraGen Pharmaceuticals Inc. (024949457)

Registrant - CitraGen Pharmaceuticals Inc. (024949457)

Name	Address	ID/FEI	Business Operations
Establishment
CitraGen Pharmaceuticals Inc		024949457	manufacture(70369-002)

Revised: 12/2020

Document Id: b7c04e09-4756-2129-e053-2995a90a09f7

Set id: 68aadbd9-f1c6-8a23-e053-2991aa0afd96

Version: 5

Effective Time: 20201231