FDA.reportPublic FDA data

NDC 70756-404-99 - 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
70756-404-99
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 8 of 110 · 2,182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Coupler LLC5087f071-5ef4-753e-e063-6294a90afb8d2026-04-28Warnings, Adverse reactionsExact identifier
application number: ANDA217357
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
NITROFURANTOINNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack8450fee6-7b9d-4c74-848e-c4f42c1963f92026-04-20Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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