O-Cal Prenatal Vitamin
O-CAL PRENATAL Vitamin & Mineral Supplement with Folic Acid
Approved
Approval ID
c78bb534-9297-4442-9cda-76eec6a8872d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2012
Manufacturers
FDA
Pharmics, Inc.
DUNS: 058560996
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vitamin A, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, FERROUS FUMARATE, Iodine, Magnesium, Zinc, and Copper
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0813-0202
Product Classification
G
Generic Name
Vitamin A, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, FERROUS FUMARATE, Iodine, Magnesium, Zinc, and Copper
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2012
FDA Product Classification
INGREDIENTS (24)
Vitamin AActive
Quantity: 2500 [iU] in 1 1
Code: 81G40H8B0T
Classification: ACTIB
Ascorbic AcidActive
Quantity: 70 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CholecalciferolActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
RiboflavinActive
Quantity: 1.6 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 1.5 mg in 1 1
Code: 8K0I04919X
Classification: ACTIB
PyridoxineActive
Quantity: 12 mg in 1 1
Code: KV2JZ1BI6Z
Classification: ACTIB
NiacinActive
Quantity: 17 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
Folic AcidActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CyanocobalaminActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CalciumActive
Quantity: 200 mg in 1 1
Code: SY7Q814VUP
Classification: ACTIB
FERROUS FUMARATEActive
Quantity: 15 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIB
MagnesiumActive
Quantity: 100 mg in 1 1
Code: I38ZP9992A
Classification: ACTIB
IodineActive
Quantity: 150 ug in 1 1
Code: 9679TC07X4
Classification: ACTIB
CopperActive
Quantity: 2 mg in 1 1
Code: 789U1901C5
Classification: ACTIB
ZincActive
Quantity: 15 mg in 1 1
Code: J41CSQ7QDS
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium PeroxideInactive
Code: 3GSN3JCJ5K
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 30 [iU] in 1 1
Code: 9E8X80D2L0
Classification: ACTIB