PRENATAL PLUS

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

New Generation Wellness

Labeler

Amneal Pharmaceuticals LLC

DUNS Number

806784679

Products1

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

Product Details

NDC Product Code

65162-668

Route of Administration

ORAL

Effective Date

March 29, 2022

Ingredients

Vitamin A acetateActive

Code: 3LE3D9D6OYClass: ACTIMQuantity: 3080 [iU] in 1 1

Beta caroteneActive

Code: 01YAE03M7JClass: ACTIBQuantity: 920 [iU] in 1 1

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 120 mg in 1 1

RiboflavinActive

Code: TLM2976OFRClass: ACTIBQuantity: 3 mg in 1 1

Vitamin D3Active

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

ThiamineActive

Code: 8K0I04919XClass: ACTIRQuantity: 1.84 mg in 1 1

NicotinamideActive

Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1

PyridoxineActive

Code: 68Y4CF58BVClass: ACTIBQuantity: 10 mg in 1 1

Calcium carbonateActive

Code: H0G9379FGKClass: ACTIMQuantity: 200 mg in 1 1

Folic acidActive

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

Vitamin B12Active

Code: P6YC3EG204Class: ACTIBQuantity: 12 ug in 1 1

Zinc oxideActive

Code: SOI2LOH54ZClass: ACTIBQuantity: 25 mg in 1 1

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

Ferrous fumarateActive

Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1

Cupric oxideActive

Code: V1XJQ704R4Class: ACTIMQuantity: 2 mg in 1 1

ASCORBYL PALMITATEInactive

Code: QN83US2B0NClass: IACT

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

.ALPHA.-TOCOPHEROL, DL-Inactive

Code: 7QWA1RIO01Class: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2DClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM ASCORBATEInactive

Code: S033EH8359Class: IACT

SORBIC ACIDInactive

Code: X045WJ989BClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SUNFLOWER OILInactive

Code: 3W1JG795YIClass: IACT

DL-alpha tocopheryl acetateActive

Code: WR1WPI7EW8Class: ACTIMQuantity: 22 mg in 1 1

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PRENATAL PLUS

FDA Approval Summary

Manufacturing Establishments1

Products1

PRENATAL PLUS

Product Details