Nauzene
Nauzene Chewables
Approved
Approval ID
a60660b2-c5db-45a0-885f-de93e655380d
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 29, 2025
Manufacturers
FDA
Kobayashi Healthcare International, Inc.
DUNS: 156391729
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52389-242
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (14)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 230 mg in 1 1
Code: B22547B95K
Classification: ACTIM