MedPath

Ultra strength Antacid

905R_CVS_51316-905_Calcium Carbonate 1000 mg-Assorted Fruit

Approved
Approval ID

2480eace-06a6-86a2-e063-6394a90a3c0c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 15, 2025

Manufacturers
FDA

CVS HEALTH CORP

DUNS: 062312574

Products 1

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

Calcium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51316-905
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2025
FDA Product Classification

INGREDIENTS (11)

CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

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Ultra strength Antacid - FDA Drug Approval Details