Label: EMBRIVA- ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tablet
- NDC Code(s): 85477-322-30
- Packager: Oncora Pharma, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated August 12, 2025
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DESCRIPTION
Each Tablet Contains:
Amount per Tablet
Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg
Ascorbic Acid...................... ......................................................... 125 mg
Folic Acid ....................................................................................... 1 mg
Colecalciferol ............................................................................. .0125 mg
Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg
Methylcobalamin.................. ........................................................ 1 mg
Calcium Carbonate ................................................................... 200 mg
Ferrous Gluconate ..................................................................... 13 mg
Potassium Iodide........................................................................ .15 mg
Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide
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INGREDIENTS AND APPEARANCE
EMBRIVA
ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:85477-322 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 2.5 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 0.15 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 125 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 0.0125 mg THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.4 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 1 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 13 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color blue Score no score Shape OVAL Size 19mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85477-322-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/08/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/08/2025 Labeler - Oncora Pharma, LLC (119482542)
