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FDA Approval

PNV Prenatal Vitamin

CompanySancilio & Company Inc (DUNS: 176681257)

Effective Date

December 14, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Vitamin B12(4.5 ug in 1 1)

Folic acid(1 mg in 1 1)

Vitamin C(60 mg in 1 1)

Ferrous fumarate(27 mg in 1 1)

Nicotinamide(13.5 mg in 1 1)

Pyridoxine(1.05 mg in 1 1)

Riboflavin(1.2 mg in 1 1)

Thiamine(1.05 mg in 1 1)

Vitamin A acetate(2500 [iU] in 1 1)

Vitamin D3(400 [iU] in 1 1)

DL-alpha tocopheryl acetate(15 [iU] in 1 1)

Potassium phosphate, dibasic, trihydrate(50 mg in 1 1)

Products (1)

PNV Prenatal Vitamin Plus Vitamin A

NDC Product Code

44946-1046

Route of Administration

ORAL

Effective Date

January 10, 2013

Ingredients

Vitamin B12Active

Code: P6YC3EG204Class: ACTIBQuantity: 4.5 ug in 1 1

Folic acidActive

Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1

Ferrous fumarateActive

Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1

NicotinamideActive

Code: 25X51I8RD4Class: ACTIBQuantity: 13.5 mg in 1 1

PyridoxineActive

Code: 68Y4CF58BVClass: ACTIBQuantity: 1.05 mg in 1 1

RiboflavinActive

Code: TLM2976OFRClass: ACTIBQuantity: 1.2 mg in 1 1

Code: 8K0I04919XClass: ACTIRQuantity: 1.05 mg in 1 1

Vitamin A acetateActive

Code: 3LE3D9D6OYClass: ACTIMQuantity: 2500 [iU] in 1 1

Croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

Vitamin D3Active

Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1

Cellulose, MicrocrystallineInactive

Code: OP1R32D61UClass: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Anhydrous Citric AcidInactive

Code: XF417D3PSLClass: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

DL-alpha tocopheryl acetateActive

Code: WR1WPI7EW8Class: ACTIMQuantity: 15 [iU] in 1 1

Potassium phosphate, dibasic, trihydrateActive

Code: L11K75P92JClass: ACTIBQuantity: 50 mg in 1 1

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