FDA.reportPublic FDA data

NDC 70756-404-50 - 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
70756-404
Requested NDC
70756-404-50
Package NDCs from labels
70756-404-11, 70756-404-51, 70756-404-50, 70756-404-99
Manufacturer
REMEDYREPACK INC.
Effective date
2026-10-16
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) Rx OnlyREMEDYREPACK INC.2026-10-16HUMAN PRESCRIPTION DRUG LABEL
NITROFURANTOIN MONOHYDRATE - Lifestar Pharma LLC | Mankind Pharma LimitedLifestar Pharma LLC | Mankind Pharma Limited2026-09-30HUMAN PRESCRIPTION DRUG LABEL
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) Rx OnlyNuCare Pharmaceuticals,Inc.2026-08-19HUMAN PRESCRIPTION DRUG LABEL
STARCH, CORN - Coupler LLC | Mankind Pharma LimitedCoupler LLC | Mankind Pharma Limited2026-05-07HUMAN PRESCRIPTION DRUG LABEL
Nitrofurantoin (monohydrate/macrocrystals) - Major PharmaceuticalsMajor Pharmaceuticals2026-04-06HUMAN PRESCRIPTION DRUG LABEL
STARCH, CORN - Redpharm Drug | Mankind Pharma LimitedRedpharm Drug | Mankind Pharma Limited2026-03-11HUMAN PRESCRIPTION DRUG LABEL
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) Rx OnlyPreferred Pharmaceuticals Inc.2026-01-16HUMAN PRESCRIPTION DRUG LABEL
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) Rx OnlyNuCare Pharmaceuticals,Inc.2025-12-10HUMAN PRESCRIPTION DRUG LABEL
Nitrofurantoin (monohydrate/macrocrystals) - Bryant Ranch PrepackBryant Ranch Prepack2025-04-10HUMAN PRESCRIPTION DRUG LABEL
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) Rx OnlyRPK Pharmaceuticals, Inc.2024-12-19HUMAN PRESCRIPTION DRUG LABEL
Nitrofurantoin (monohydrate/macrocrystals) - Proficient Rx LPProficient Rx LP2024-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-404-11Nitrofurantoin (monohydrate/macrocrystals)100 in 1 BOTTLECAPSULE1004
70756-404-51Nitrofurantoin (monohydrate/macrocrystals)500 in 1 BOTTLECAPSULE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-404NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [LIFESTAR PHARMA LLC]4Current NDC, 2 package rows20230914_35c0a6d8-ff85-4d9b-9ad3-ae20808119dd.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 3 of 110 · 2,182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.ae892973-9ef4-4cf0-baf3-fbe158697bac2026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Nitrofurantoin Monohydrate/ MacrocrystallineNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEREMEDYREPACK INC.a4afd48b-003f-4ffa-9ca0-9432b8b0e22b2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)BluePoint Laboratoriesea28d766-d6e6-43d2-8282-dc78a03810572026-06-24Warnings, Adverse reactionsExact identifier
application number: ANDA217357
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L

Reported adverse events (FAERS/openFDA)#

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