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 84 of 142 · 2,831 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM231ABROTANUM, ANTI IOD, ARSENIC IOD, BARYTA CARB, CALC PHOS, FERR MET, KALI IOD, SILICEABestmade Natural Products2f81507c-b5b0-a976-e063-6394a90a869e2025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM237BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEABestmade Natural Products2f82f2c4-a549-9e17-e063-6394a90aea812025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: ETJ7Z6XBU4
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
unii: 15FIX9V2JP
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
unii: 15FIX9V2JP
SiliceaSILICON DIOXIDEWashington Homeopathic Products2ee71a08-f69b-e2ef-e063-6394a90ab9902025-02-24WarningsExact identifier
unii: ETJ7Z6XBU4
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM186ARNICA, FERR. PHOS, IGNATIA, SILICA, HYPERICUMBestmade Natural Products2e9437ae-59fa-c646-e063-6294a90ac0f62025-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM173ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBestmade Natural Products2e7de086-a4c1-ae9e-e063-6394a90aa5f52025-02-19WarningsExact identifier
unii: ETJ7Z6XBU4
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM146ACID SULPH, APIS MELL, ARNICA MONT, CALENDULA OFF, HAMAMELIS, IODIUM, LYCOPODIUM, SILICEABestmade Natural Products2e69161f-e4e2-a5cc-e063-6394a90a476f2025-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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