Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bisacodyl
Product Details
NDC Product Code
71335-2010Application Number
505G(a)(3)Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
March 31, 2025BisacodylActive
Code: 10X0709Y6IClass: ACTIBQuantity: 5 mg in 1 1
ACACIAInactive
Code: 5C5403N26OClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGKClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT