MedPath

Calcium Carbonate

124 -Calcium Carbonate 500mg

Approved
Approval ID

5397b702-5920-4af9-8cc5-e7fe6e2c1021

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 1, 2025

Manufacturers
FDA

Allegiant Health

DUNS: 079501930

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Antacid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69168-124
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Antacid
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (5)

CALCIUM CARBONATEActive
Quantity: 500 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Calcium Carbonate - FDA Drug Approval Details