Macrobid
Macrobid (Nitrofurantoin Capsules, USP)
Approved
Approval ID
8f270a9f-12a1-44d4-bc7e-873613555801
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2023
Manufacturers
FDA
Almatica Pharma LLC
DUNS: 962454505
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitrofurantoin Monohydrate/Macrocrystalline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-285
Application NumberNDA020064
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitrofurantoin Monohydrate/Macrocrystalline
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2012
FDA Product Classification
INGREDIENTS (14)
NITROFURANTOINActive
Quantity: 25 mg in 1 1
Code: 927AH8112L
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
NITROFURANTOIN MONOHYDRATEActive
Quantity: 75 mg in 1 1
Code: E1QI2CQQ1I
Classification: ACTIM