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FDA Approval

PRENATAL PLUS

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
AvPAK
DUNS: 832926666
Effective Date
April 12, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Folic acid(1 mg in 1 1)
Calcium carbonate(200 mg in 1 1)
Zinc oxide(25 mg in 1 1)
Vitamin A acetate(3080 [iU] in 1 1)
Beta carotene(920 [iU] in 1 1)
Vitamin C(120 mg in 1 1)
Vitamin D3(400 [iU] in 1 1)
Thiamine(1.84 mg in 1 1)
Riboflavin(3 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Pyridoxine(10 mg in 1 1)
Vitamin B12(12 ug in 1 1)
Ferrous fumarate(27 mg in 1 1)
Cupric oxide(2 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PRENATAL PLUS

Product Details

NDC Product Code
50268-677
Route of Administration
ORAL
Effective Date
April 12, 2022
ASCORBYL PALMITATEInactive
Code: QN83US2B0NClass: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01Class: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YIClass: IACT
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: H0G9379FGKClass: ACTIMQuantity: 200 mg in 1 1
Code: SOI2LOH54ZClass: ACTIBQuantity: 25 mg in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Code: 3LE3D9D6OYClass: ACTIMQuantity: 3080 [iU] in 1 1
Code: 01YAE03M7JClass: ACTIBQuantity: 920 [iU] in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 120 mg in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.84 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 3 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 10 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 12 ug in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1
Code: V1XJQ704R4Class: ACTIMQuantity: 2 mg in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 9.9 mg in 1 1
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