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FDA Approval

Concept OB

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

FDA Approval Summary

Company
U.S. Pharmaceutical Corporation
DUNS: 079467662
Effective Date
November 8, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Folic acid(1 mg in 1 1)
Riboflavin(5 mg in 1 1)
Pantothenic acid(7 mg in 1 1)
Thiamine(5 mg in 1 1)
Ferrous fumarate(42.5 mg in 1 1)
Iron(42.5 mg in 1 1)
Vitamin C(210 mg in 1 1)
Niacin(20 mg in 1 1)
Biotin(300 ug in 1 1)
Pyridoxine(25 mg in 1 1)
Vitamin B12(10 ug in 1 1)
Cupric sulfate(800 ug in 1 1)
Manganese sulfate(1.3 mg in 1 1)

Products1

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

Concept OB

Product Details

NDC Product Code
52747-620
Route of Administration
ORAL
Effective Date
July 13, 2022
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 5 mg in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 7 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 5 mg in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 42.5 mg in 1 1
IronActive
Code: E1UOL152H7Class: ACTIBQuantity: 42.5 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 210 mg in 1 1
NiacinActive
Code: 2679MF687AClass: ACTIBQuantity: 20 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 300 ug in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Code: 68Y4CF58BVClass: ACTIMQuantity: 25 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 10 ug in 1 1
Code: LRX7AJ16DTClass: ACTIMQuantity: 800 ug in 1 1
Code: W00LYS4T26Class: ACTIMQuantity: 1.3 mg in 1 1
Code: 89DS0H96TBClass: ACTIMQuantity: 18.2 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
Code: DE08037SABClass: ACTIBQuantity: 6.9 mg in 1 1
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