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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
Effective Date
April 2, 2013
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin A acetate(3080 [iU] in 1 1)
.beta.-carotene(920 [iU] in 1 1)
Vitamin D3(400 [iU] in 1 1)
Vitamin C(120 mg in 1 1)
Riboflavin(3 mg in 1 1)
Thiamine(1.84 mg in 1 1)
Pyridoxine(10 mg in 1 1)
Folic acid(1 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Vitamin B12(12 ug in 1 1)
Calcium carbonate(200 mg in 1 1)
Ferrous fumarate(27 mg in 1 1)
Zinc oxide(25 mg in 1 1)
Cupric oxide(2 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Carilion Materials Management

079239644

Manufacturing Establishments1

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

Carilion Materials Management

Carilion Materials Management

Carilion Materials Management

079239644

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
68151-2640
Route of Administration
ORAL
Effective Date
April 1, 2013
Code: 3LE3D9D6OYClass: ACTIMQuantity: 3080 [iU] in 1 1
.beta.-caroteneActive
Code: 01YAE03M7JClass: ACTIBQuantity: 920 [iU] in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 120 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 3 mg in 1 1
ThiamineActive
Code: X66NSO3N35Class: ACTIBQuantity: 1.84 mg in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 10 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 12 ug in 1 1
Code: H0G9379FGKClass: ACTIBQuantity: 200 mg in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1
Code: SOI2LOH54ZClass: ACTIBQuantity: 25 mg in 1 1
ASCORBYL PALMITATEInactive
Code: QN83US2B0NClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: V1XJQ704R4Class: ACTIMQuantity: 2 mg in 1 1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01Class: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YIClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Code: WR1WPI7EW8Class: ACTIMQuantity: 22 mg in 1 1
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