FDA.reportPublic FDA data

NDC 68788-8258-08 - 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
68788-8258
Requested NDC
68788-8258-08
Package NDCs from labels
68788-8258-0, 68788-8258-1, 68788-8258-8, 68788-8258-08
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-08-04
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)Preferred Pharmaceuticals Inc.2026-08-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8258-0Nitrofurantoin10 in 1 BOTTLECAPSULE105
68788-8258-1Nitrofurantoin14 in 1 BOTTLECAPSULE145
68788-8258-8Nitrofurantoin28 in 1 BOTTLECAPSULE285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8258NITROFURANTOIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240725_729f6bbb-ab64-4b65-979a-4ad7605c5947.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8258-0EA - Each68788-8258b29d5013-7e21-4ed3-833a-55cbd3c522aa12022-10-06
68788-8258-1EA - Each68788-82580b790a87-aac4-471e-8516-7b2cab49f0b712022-10-06

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
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NitrofurantoinNITROFURANTOINPreferred Pharmaceuticals Inc.729f6bbb-ab64-4b65-979a-4ad7605c59472026-08-04Warnings, Adverse reactionsExact identifier
application number: ANDA208516
ndc (package): 68788-8258-1
ndc (package): 68788-8258-8
ndc (package): 68788-8258-0
ndc (product): 68788-8258
ndc11 (package): 68788825808
rxcui: 1648755
spl id: 86ac0486-a85c-419b-8a46-ec0ef2f82d8f
spl set id: 729f6bbb-ab64-4b65-979a-4ad7605c5947
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.