MedPath

Laxative

Meijer 44-676A RESERVED 79481-6760

Approved
Approval ID

4fd4dc2c-9617-4fc9-927d-7835f7fbcde3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 24, 2025

Manufacturers
FDA

Meijer Distribution, Inc.

DUNS: 006959555

Products 1

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

Bisacodyl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79481-6760
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bisacodyl
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2025
FDA Product Classification

INGREDIENTS (21)

BISACODYLActive
Quantity: 5 mg in 1 1
Code: 10X0709Y6I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

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Laxative - FDA Drug Approval Details