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 93 of 142 · 2,831 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revlon PhotoReady BB Cream Skin PerfectorOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410ca372-4698-029d-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Oily to Combination SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410d1cb2-6c92-1ca3-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
REVLON PHOTOREADY INSTA-FIX MAKEUPTITANIUM DIOXIDE, ZINC OXIDERevlon Consumer Products Corp442f2a06-47c0-2522-e054-00144ff88e882024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Youth FXZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp442dec1e-032c-28de-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup MediumTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a971e38-af63-e069-e063-6294a90a8f772024-12-31WarningsExact identifier
unii: 15FIX9V2JP
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.68a651f9-1aef-792e-e053-2991aa0a3cbb2024-12-30Warnings, Adverse reactionsExact identifier
application number: ANDA077066
ndc (package): 68071-4367-4
ndc (package): 68071-4367-2
ndc (package): 68071-4367-1
ndc (product): 68071-4367
ndc11 (package): 68071436701
rxcui: 1648755
spl id: 2a81d529-e3bd-721c-e063-6394a90a0222
spl set id: 68a651f9-1aef-792e-e053-2991aa0a3cbb
unii: E1QI2CQQ1I
unii: 927AH8112L
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
unii: 15FIX9V2JP
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
unii: 15FIX9V2JP
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
unii: 15FIX9V2JP
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: C151H8M554
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLCee7e2ded-b850-4e15-96a6-556111e521872024-12-25WarningsExact identifier
unii: 15FIX9V2JP
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd1a3d76f-16dd-4533-8144-9a3175f6e15f2024-12-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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