FDA.reportPublic FDA data

NDC 70518-3717-00 - Nitrofurantoin

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
70518-3717
Requested NDC
70518-3717-00
Package NDCs from labels
70518-3717-0, 70518-3717-1, 70518-3717-2, 70518-3717-3, 70518-3717-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-19
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)REMEDYREPACK INC.2026-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3717-0Nitrofurantoin14 in 1 BOTTLE, PLASTICCAPSULE149
70518-3717-1Nitrofurantoin30 in 1 BLISTER PACKCAPSULE309
70518-3717-2Nitrofurantoin10 in 1 BOTTLE, PLASTICCAPSULE109
70518-3717-3Nitrofurantoin20 in 1 BOTTLE, PLASTICCAPSULE209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3717NITROFURANTOIN CAPSULE [REMEDYREPACK INC.]6Current NDC, 4 package rows20240329_6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5.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 1 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.4553ccc1-0bad-4c75-aae2-1a1c87bc8db02026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NITROFURANTOINNITROFURANTOINREMEDYREPACK INC.87505f8f-2056-4e55-adf5-5b7309081d7c2026-09-01Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.e55f3dc2-c754-4550-a2c0-c304471a87912026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NitrofurantoinNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.10e2503d-a250-996f-e063-6294a90abd612026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NitrofurantoinNITROFURANTOINREMEDYREPACK INC.6c82b95d-2c32-4e54-a8a9-a4bb4df70cb52026-08-19Warnings, Adverse reactionsExact identifier
application number: ANDA208516
ndc (package): 70518-3717-1
ndc (package): 70518-3717-0
ndc (package): 70518-3717-2
ndc (package): 70518-3717-3
ndc (product): 70518-3717
ndc11 (package): 70518371700
rxcui: 1648755
spl id: 596c5a11-5d18-f6eb-e063-6394a90a58eb
spl set id: 6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5
unii: E1QI2CQQ1I
unii: 927AH8112L
NitrofurantoinNITROFURANTOINPreferred Pharmaceuticals Inc.729f6bbb-ab64-4b65-979a-4ad7605c59472026-08-04Warnings, Adverse reactionsExact identifier
application number: ANDA208516
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSPD-Rx Pharmaceuticals, Inc.536ed022-db80-492d-b6ab-809855ea90fb2026-07-17Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.ae892973-9ef4-4cf0-baf3-fbe158697bac2026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
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
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSBluePoint Laboratoriescfa20cfd-478f-48c6-9b59-3c425abd766a2026-06-24Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantionNITROFURANTIONBryant Ranch Prepackeeb12928-61ab-42a0-a1fa-2819b9ffa3cb2026-06-24Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantoinNITROFURANTOINSt. Mary's Medical Park Pharmacy09944470-807d-ad37-e063-6394a90a7bfe2026-06-23Warnings, Adverse reactionsExact identifier
application number: ANDA208516
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NITROFURANTOINNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)A-S Medication Solutionsb6c5bbb0-86db-4a76-a1eb-98573a0b0adc2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSREMEDYREPACK INC.27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a12026-06-09Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)St. Mary's Medical Park Pharmacy87210c87-b7db-0f65-e053-2a91aa0a43932026-06-07Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Coupler LLC513b514f-6e79-f187-e063-6394a90a07dc2026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Coupler LLC5087f071-5ef4-753e-e063-6294a90afb8d2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NITROFURANTOINNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack8450fee6-7b9d-4c74-848e-c4f42c1963f92026-04-20Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAmneal Pharmaceuticals of New York LLC341c75ac-fba5-480d-a221-868c4195cb6f2026-04-14Warnings, Adverse reactionsExact identifier
unii: 927AH8112L

Reported adverse events (FAERS/openFDA)#

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