PNV Prenatal Vitamin
PNV Prenatal Health™ - Prenatal Vitamins
Approved
Approval ID
97b99e3f-0bc6-46a5-956d-9141d22f3d87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2012
Manufacturers
FDA
Sancilio & Company Inc
DUNS: 176681257
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
.Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, and Vitamin A Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44946-1046
Product Classification
G
Generic Name
.Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, and Vitamin A Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2013
FDA Product Classification
INGREDIENTS (17)
CyanocobalaminActive
Quantity: 4.5 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
Folic AcidActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
Ascorbic AcidActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
Ferrous fumarateActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
NiacinamideActive
Quantity: 13.5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
Pyridoxine HydrochlorideActive
Quantity: 1.05 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
RiboflavinActive
Quantity: 1.2 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
Thiamine MononitrateActive
Quantity: 1.05 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
Vitamin A AcetateActive
Quantity: 2500 [iU] in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
CholecalciferolActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
.Alpha.-Tocopherol Acetate, DL-Active
Quantity: 15 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
Calcium Phosphate, Dibasic, AnhydrousActive
Quantity: 50 mg in 1 1
Code: L11K75P92J
Classification: ACTIB