NDC 51079-348-01 - 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
51079-348
Requested NDC
51079-348-01
Package NDCs from labels
51079-348-01, 51079-348-20
Manufacturer
Mylan Institutional Inc.
Effective date
2018-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nitrofurantoin Monohydrate/Macrocrystals - Mylan Institutional Inc.Mylan Institutional Inc.2018-12-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-348-01EA - Each51079-3489a545b61-eb3b-4870-84e1-39696f247bcf12012-07-24
51079-348-20EA - Each51079-3483d6a85d6-290a-475c-a1af-cb9b2999aaef12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1INITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ONITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN MONOHYDRATE/MACROCRYSTALS (NITROFURANTOIN MONOHYDRATE/NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [MYLAN INSTITUTIONAL INC.]2

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 1 of 117 · 2,332 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.4553ccc1-0bad-4c75-aae2-1a1c87bc8db02026-09-08Warnings, Adverse reactionsExact identifier
unii: E1QI2CQQ1I
unii: 927AH8112L
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
NITROFURANTOINNITROFURANTOINREMEDYREPACK INC.87505f8f-2056-4e55-adf5-5b7309081d7c2026-09-01Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.e55f3dc2-c754-4550-a2c0-c304471a87912026-08-26Warnings, Adverse reactionsExact identifier
unii: E1QI2CQQ1I
unii: 927AH8112L
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
NitrofurantoinNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.10e2503d-a250-996f-e063-6294a90abd612026-08-19Warnings, Adverse reactionsExact identifier
unii: E1QI2CQQ1I
unii: 927AH8112L
NitrofurantoinNITROFURANTOINREMEDYREPACK INC.6c82b95d-2c32-4e54-a8a9-a4bb4df70cb52026-08-19Warnings, Adverse reactionsExact identifier
unii: E1QI2CQQ1I
unii: 927AH8112L
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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