Prenaissance
Prenaissance Capsules
Approved
Approval ID
7240d5fb-cb2d-4278-988f-c8e6bba6560d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Acella Pharmaceuticals, LLC
DUNS: 825380939
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42192-341
Product Classification
G
Generic Name
CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2018
FDA Product Classification
INGREDIENTS (19)
ASCORBIC ACIDActive
Quantity: 28 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
TRICALCIUM PHOSPHATEActive
Quantity: 160 mg in 1 1
Code: K4C08XP666
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 29 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 800 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1.25 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
DOCONEXENTActive
Quantity: 325 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
DOCUSATE SODIUMActive
Quantity: 55 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJ
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
.ALPHA.-TOCOPHEROL, D-Active
Quantity: 30 [iU] in 1 1
Code: N9PR3490H9
Classification: ACTIB