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NDC 70369-0004-01 Calcium Carbonate 648 mg/1 Details

Calcium Carbonate 648 mg/1

Calcium Carbonate is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by CitraGen Pharmaceuticals, Inc.. The primary component is CALCIUM CARBONATE.

MedlinePlus Drug Summary

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 70369-0004-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	70369-0004
Product ID	70369-004_b7c04e09-4757-2129-e053-2995a90a09f7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Calcium Carbonate
Proprietary Name Suffix	10 gr (648 mg)
Non-Proprietary Name	Calcium Carbonate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	648
Active Ingredient Units	mg/1
Substance Name	CALCIUM CARBONATE
Labeler Name	CitraGen Pharmaceuticals, Inc.
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70369-0004-01 (70369000401)

Pricing Information	N/A
NDC Package Code	70369-004-01
Billing NDC	70369000401
Package	1000 TABLET in 1 BOTTLE (70369-004-01)
Marketing Start Date	2018-08-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 723b940d-4f4b-f2e6-e053-2991aa0a8bcc Details

Drug Facts

Active ingredient (in each tablet)

Calcium carbonate 10 gr (648 mg)

Purpose

Antacid / Calcium Supplement

Uses

relieves:

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Warnings

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.

Directions

take one to four tablets daily
do not take more than 4 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks

Other information

each tablet contains: Calcium 260 mg

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

Inactive ingredients

Hydrogenated Vegetable Oil, Maltodextrin and Microcrystalline Cellulose

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. 07/18 R-00

PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369-004-01

Calcium Carbonate Tablets, USP 10 gr (648 mg)

ANTACID / Calcium Supplement

1000 Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

CALCIUM CARBONATE 10 GR (648 MG)

calcium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70369-004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	648 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	CG004
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70369-004-01	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	08/07/2018

Labeler - CitraGen Pharmaceuticals, Inc. (024949457)

Registrant - CitraGen Pharmaceuticals, Inc. (024949457)

Name	Address	ID/FEI	Business Operations
Establishment
CitraGen Pharmaceuticals, Inc.		024949457	manufacture(70369-004)

Revised: 12/2020

Document Id: b7c04e09-4757-2129-e053-2995a90a09f7

Set id: 723b940d-4f4b-f2e6-e053-2991aa0a8bcc

Version: 3

Effective Time: 20201231