nitrofurantoin macrocrystals
Nitrofurantoin Capsules, USP (Macrocrystals)Rx only
Approved
Approval ID
6ec66cc8-938f-4839-98c7-a51c9f1d50ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Lifestar Pharma LLC
DUNS: 080268943
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitrofurantoin macrocrystals
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-410
Application NumberANDA217272
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitrofurantoin macrocrystals
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROFURANTOINActive
Quantity: 25 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
nitrofurantoin macrocrystals
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-412
Application NumberANDA217272
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitrofurantoin macrocrystals
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROFURANTOINActive
Quantity: 100 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
nitrofurantoin macrocrystals
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-411
Application NumberANDA217272
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitrofurantoin macrocrystals
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (11)
NITROFURANTOINActive
Quantity: 50 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT