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FDA Approval

Nestabs ONE

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

FDA Approval Summary

Effective Date
April 15, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Iron(38 mg in 1 1)
Zinc oxide(1 mg in 1 1)
Folic acid(1 mg in 1 1)
Antazoline(225 mg in 1 1)
Tocopherol(10 mg in 1 1)
Calcium ascorbate(18 mg in 1 1)
Vitamin B12(15 ug in 1 1)
Magnesium oxide(15 mg in 1 1)
Vitamin D3(6.25 ug in 1 1)
Pyridoxine(30 mg in 1 1)

Products1

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

Nestabs ONE

Product Details

NDC Product Code
50967-410
Route of Administration
ORAL
Effective Date
April 15, 2022
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
IronActive
Code: E1UOL152H7Class: ACTIBQuantity: 38 mg in 1 1
Code: SOI2LOH54ZClass: ACTIBQuantity: 1 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: DHA8014SS1Class: ACTIBQuantity: 225 mg in 1 1
Code: R0ZB2556P8Class: ACTIBQuantity: 10 mg in 1 1
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
WHITE WAXInactive
Code: 7G1J5DA97FClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
Code: 183E4W213WClass: ACTIMQuantity: 18 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 15 ug in 1 1
Code: 3A3U0GI71GClass: ACTIMQuantity: 15 mg in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 6.25 ug in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 30 mg in 1 1
WATERInactive
Code: 059QF0KO0RClass: IACT
GELATIN TYPE B BOVINE (160 BLOOM)Inactive
Code: 1T8387508XClass: IACT
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