TriStart DHA
TriStart DHA PRENATAL SUPPLEMENT
Approved
Approval ID
92ccf7d4-4527-49f0-b890-1a11b5a10086
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
CarWin Pharmaceutical Associates, LLC
DUNS: 079217215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, and ICOSAPENT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-250
Product Classification
G
Generic Name
ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, and ICOSAPENT
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2019
FDA Product Classification
INGREDIENTS (23)
ASCORBIC ACIDActive
Quantity: 55 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, D-Active
Quantity: 15 [iU] in 1 1
Code: A7E6112E4N
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 1000 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
NIACINActive
Quantity: 5 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
THIAMINE HYDROCHLORIDEActive
Quantity: 1.3 mg in 1 1
Code: M572600E5P
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.8 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 35 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 400 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
LEVOMEFOLATE MAGNESIUMActive
Quantity: 600 ug in 1 1
Code: 1VZZ62R081
Classification: ACTIM
DOCONEXENTActive
Quantity: 200 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 14 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
POTASSIUM IODIDEActive
Quantity: 200 ug in 1 1
Code: 1C4QK22F9J
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 30 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
ICOSAPENTActive
Quantity: 15 mg in 1 1
Code: AAN7QOV9EA
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJ
Classification: IACT
IRON PENTACARBONYLActive
Quantity: 31 mg in 1 1
Code: 6WQ62TAQ6Z
Classification: ACTIM