FDA.reportPublic FDA data

NDC 0149-0710 - Macrobid

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
0149-0710
Package NDCs from labels
0149-0710-01
Manufacturer
Procter and Gamble Pharmaceuticals, Inc.
Effective date
2009-03-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Macrobid ® (nitrofurantoin monohydrate/macrocrystals) CapsulesProcter and Gamble Pharmaceuticals, Inc.2009-03-23HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0149-0710-01Macrobid100 in 1 BOTTLECAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0149-0710MACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]51 package rows20090421_1971e893-5fdb-41e3-a1e9-5e52deed03d1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nitrofurantoin monohydrateACTIVE INGREDIENTE1QI2CQQ1IMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
nitrofurantoin, macrocrystallineACTIVE INGREDIENT927AH8112LMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
nitrofurantoinACTIVE MOIETY927AH8112LMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
carbomer 934PINACTIVE INGREDIENTMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
compressible sugarINACTIVE INGREDIENTMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
corn starchINACTIVE INGREDIENTO8232NY3SJMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
D&C Yellow No. 10INACTIVE INGREDIENTMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
edible gray inkINACTIVE INGREDIENTMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
FD&C Blue No. 1INACTIVE INGREDIENTMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
FD&C Red No. 40INACTIVE INGREDIENTMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
gelatinINACTIVE INGREDIENT2G86QN327LMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
lactoseINACTIVE INGREDIENTJ2B2A4N98GMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30MACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
povidoneINACTIVE INGREDIENTFZ989GH94EMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
talcINACTIVE INGREDIENT7SEV7J4R1UMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMACROBID (NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN, MACROCRYSTALLINE) CAPSULE [PROCTER AND GAMBLE PHARMACEUTICALS, INC.]5

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 2 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Preferred Pharmaceuticals Inc.11e8f91c-5712-4267-9956-e619d081d1f42026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOINNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)A-S Medication Solutions2a772eb3-4fb3-4d92-b9f4-469dd22163612026-01-06Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)PD-Rx Pharmaceuticals, Inc.7767697f-4dd0-477d-b5cc-e1ed5689f0972026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)PD-Rx Pharmaceuticals, Inc.643cdcff-8599-4326-b3ca-d9fd270e0fc22026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Northwind Health Company, LLC04b4189e-9b21-78ed-e063-6394a90ab8e02026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)QPharma, Inc.fbc05ccb-782b-55f6-e053-6394a90a7fd62025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.155c8d68-576e-f85c-e063-6294a90ada4b2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Redpharm Drug3dd034a6-8810-93f5-e063-6394a90a36c22025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)QPharma, Inc.055477be-e42c-fe8b-e063-6394a90a04492025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINBryant Ranch Prepack1c5db054-58af-4932-8fad-c3883b13f9872025-10-22Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin Monohydrate/ MacrocrystallineNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEAlvogen Inc.1a86deef-0887-43b1-bb96-dbc222b159312025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINPD-Rx Pharmaceuticals, Inc.d88348a0-6ab4-4490-9325-1f14a541b0a52025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 1648755
MacrobidNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEAlmatica Pharma LLC8f270a9f-12a1-44d4-bc7e-8736135558012025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 539712
rxcui: 1648755
NitrofurantoinNITROFURANTOINPD-Rx Pharmaceuticals, Inc.37606c6f-0d85-4314-94ae-f7732c7bc8d52025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)A-S Medication Solutionsb644426c-c8ba-4fe0-80c7-d9b2dde373952025-08-13Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDirect_Rx8d2e456a-ffb2-3f1e-e053-2995a90a22df2025-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Jubilant Cadista Pharmaceuticals Inc.1f7a9414-5592-f2ca-e063-6394a90a75f42025-06-30Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINMicro Labs Limitedd96098d0-3c2b-4e53-a3f0-3ebba81c41332025-05-14Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack63a4b367-bf4b-4b5f-b3e9-394ba307886d2025-04-10Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINRedpharm Drug, Inc.f4c2c01d-bef7-3e5d-e053-2995a90ae0d82025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 1648755

Reported adverse events (FAERS/openFDA)#

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