Dotremin
(Folic Acid, Vitamin D3 Tablet) Rx Only 11-24-2021 - Edit marketing date from 11-29-2021 to 03-01-2022.
Approved
Approval ID
cd132db2-7ff7-a9eb-e053-2995a90a02c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2022
Manufacturers
FDA
PureTek Corporation
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Folic Acid, Vitamin D3
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-524
Product Classification
G
Generic Name
Folic Acid, Vitamin D3
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2022
FDA Product Classification
INGREDIENTS (8)
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
VITAMIN DActive
Quantity: 250 ug in 1 1
Code: 9VU1KI44GP
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT