FDA.reportPublic FDA data

NDC 68071-4367-01 - Nitrofurantoin (monohydrate/macrocrystals)

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-4367
Requested NDC
68071-4367-01
Package NDCs from labels
68071-4367-4, 68071-4367-2, 68071-4367-1, 68071-4367-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)NuCare Pharmaceuticals,Inc.2024-12-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4367-22023-02-22Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42023-02-22Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-22023-01-30Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42023-01-30Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-22021-02-16Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42021-02-16Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-22021-01-29Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42021-01-29Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4367-1Nitrofurantoin (monohydrate/macrocrystals)10 in 1 BOTTLECAPSULE106
68071-4367-2Nitrofurantoin (monohydrate/macrocrystals)20 in 1 BOTTLECAPSULE206
68071-4367-4Nitrofurantoin (monohydrate/macrocrystals)14 in 1 BOTTLECAPSULE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4367NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20250101_68a651f9-1aef-792e-e053-2991aa0a3cbb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 71 of 142 · 2,831 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENKRX RESOURCES SDN. BHD.22b8856b-671f-def3-e063-6394a90a4ea02025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted Sunscreen Medium DarkCLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARKKRX RESOURCES SDN. BHD.22cead37-f862-e859-e063-6394a90a86ce2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERKRX RESOURCES SDN. BHD.22a60fb9-0fea-92c0-e063-6394a90a088c2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
Nitrofurantoin Monohydrate/ MacrocrystallineNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEAlvogen Inc.1a86deef-0887-43b1-bb96-dbc222b159312025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD41197bb6-f6f4-c86d-e063-6294a90ad4762025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
NitrofurantoinNITROFURANTOINPD-Rx Pharmaceuticals, Inc.d88348a0-6ab4-4490-9325-1f14a541b0a52025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd4114ab09-1115-6b0b-e063-6394a90ab4422025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd41155922-d7ac-0a7a-e063-6294a90afe482025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD41157552-2473-176b-e063-6294a90a9ad02025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.