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kirkland signature acid controller

Costco Wholesale Corp. Acid Controller Drug Facts

Approved
Approval ID

311a3ef6-f684-82c9-e063-6294a90a7d05

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jan 1, 2023

Manufacturers
FDA

Praxis, LLC

DUNS: 016329513

Products 1

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

Famotidine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59368-333
Application NumberANDA077351
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification

INGREDIENTS (11)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB

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kirkland signature acid controller - FDA Drug Approval Details