FDA.reportPublic FDA data

NDC 63629-2464-01 - 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
63629-2464
Requested NDC
63629-2464-01
Package NDCs from labels
63629-2464-1, 63629-2464-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nitrofurantoin - Bryant Ranch PrepackBryant Ranch Prepack2024-03-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2464-1Nitrofurantoin100 in 1 BOTTLECAPSULE100111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2464NITROFURANTOIN CAPSULE [BRYANT RANCH PREPACK]111Current NDC, Legacy NDC, 1 package rows20240806_bebbe5d6-f6ec-4191-bad3-b6e933da0688.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2464-1EA - Each63629-2464314d3428-f497-4c5d-8e66-39090420fa3612021-04-08

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 4 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROFURANTOINNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Aurobindo Pharma Limited788f1fe3-d8a1-42cc-9280-07f842da34ea2024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NITROFURANTOINNITROFURANTOINBiocon Pharma Inc68c718a7-2e8f-288c-37d2-053372ee61b92024-11-14Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN MONOHYDRATE/MACROCRYSTALSAmneal Pharmaceuticals LLC55c75f27-b5fc-4f19-8607-08f8ec0c69ec2024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NitrofurantoinNITROFURANTOINAmneal Pharmaceuticals LLC11dcea9c-0c62-4153-976b-bd1f8ef1f6d92024-10-30Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
nitrofurantoin (macrocrystals)NITROFURANTOIN (MACROCRYSTALS)A-S Medication Solutionsbc90b22e-e48a-4a22-b328-ca5bb25618642024-10-15Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantoinNITROFURANTOINANI Pharmaceuticals, Inc.3b377aff-2d4b-43ea-84c9-8e72c1421b7b2024-10-08Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
nitrofurantoin (macrocrystals)NITROFURANTOIN (MACROCRYSTALS)Aurobindo Pharma Limitedb2fc8354-b413-4c9d-88ec-ccc43d059d512024-10-05Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantoinNITROFURANTOINBryant Ranch Prepack56e07ad3-7224-4aaf-9a68-0d48d4abfec82024-08-28Warnings, Adverse reactionsExact identifier
application number: ANDA208516
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Jubilant Cadista Pharmaceuticals Inc.266824c7-7e9f-4c5f-b642-3bb7bf1c4fe62024-08-27Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSProficient Rx LPef7053f3-3081-49c4-9c78-d40a01177fd92024-08-19Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Proficient Rx LPf49f586a-79f0-4731-97f9-9aeb0839ece52024-08-19Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
nitrofurantoinNITROFURANTOIN MACROCRYSTALSA-S Medication Solutions4cd9e234-a2b9-4201-b8f8-cf37c0672de72024-08-15Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
Nitrofurantoin Monohydrate/MacrocrystalNITROFURANTOIN MONOHYDRATE/MACROCRYSTALDirect_Rxee13cf2a-cde0-8ab8-e053-2a95a90a9dda2024-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA208516
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.6bccbaab-151b-4a04-e053-2991aa0ae1052024-06-10Warnings, Adverse reactionsExact identifier
rxcui: 1648755
unii: E1QI2CQQ1I
unii: 927AH8112L
nitrofurantoinNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepackaca04d52-8a64-4fca-94b2-64b46f5a32182024-05-17Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantoinNITROFURANTOINRising Pharma Holdings, Inc.11e700aa-66f9-4939-8a6b-a23240ae1a0b2024-05-16Warnings, Adverse reactionsExact identifier
unii: E1QI2CQQ1I
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAmerican Health Packagingce4afef1-22c1-4a1c-a102-a32fb6a2e0452024-04-28Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantoinNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepackc335f76b-6b85-4c9f-bbfa-95514cdd80fa2024-04-08Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantoinNITROFURANTOINNorthStar Rx LLC04af8b73-7e15-7da8-e063-6294a90af2842024-03-29Warnings, Adverse reactionsExact identifier
unii: 927AH8112L
NitrofurantoinNITROFURANTOINAurobindo Pharma Limitede9d10eaa-cf9c-469e-82ef-5af7285f2c862024-03-15Warnings, Adverse reactionsExact identifier
unii: E1QI2CQQ1I

Reported adverse events (FAERS/openFDA)#

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