NDC Code(s) : 0178-0813-30
Packager : Mission Pharmacal Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CitraNatal Bloomiron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0813
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID138 mg
IRON PENTACARBONYL(UNII: 6WQ62TAQ6Z)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION88.5 mg
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
(DOCUSATE - UNII:M7P27195AG) 		DOCUSATE SODIUM55 mg
FERROUS GLUCONATE(UNII: U1B11I423Z)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION13.2 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID1.4 mg
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN16.8 ug
Inactive Ingredients
Ingredient Name Strength
POVIDONE(UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
MAGNESIUM SILICATE(UNII: 9B9691B2N9)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ETHYL VANILLIN(UNII: YC9ST449YJ)
Product Characteristics
Color green Score no score
Shape RECTANGLE (modified rectangle) Size 9 mm
Flavor Imprint Code CB
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0178-0813-3030 in 1 BOTTLE Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2017 06/01/2024

LABELER - Mission Pharmacal Company(008117095)

REGISTRANT - Mission Pharmacal Company(927726893)

Establishment
Name Address ID/FEI Business Operations
Mission Pharmacal Company 927726893 manufacture(0178-0813)

PRINCIPAL DISPLAY PANEL

CitraNatal Bloom Label

Label