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 3 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NCS HealthCare of KY, LLC dba Vangard Labsd1825b58-2c00-475d-8d9b-cc07c66383f52025-01-15Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Asclemed USA, Inc.ee3f300a-d6d3-49c4-bd60-425f04d30b882025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.68a651f9-1aef-792e-e053-2991aa0a3cbb2024-12-30Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOINNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Aurobindo Pharma Limited788f1fe3-d8a1-42cc-9280-07f842da34ea2024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN MONOHYDRATE/MACROCRYSTALSAmneal Pharmaceuticals LLC55c75f27-b5fc-4f19-8607-08f8ec0c69ec2024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINBryant Ranch Prepack56e07ad3-7224-4aaf-9a68-0d48d4abfec82024-08-28Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NITROFURANTOIN (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Jubilant Cadista Pharmaceuticals Inc.266824c7-7e9f-4c5f-b642-3bb7bf1c4fe62024-08-27Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Proficient Rx LPf49f586a-79f0-4731-97f9-9aeb0839ece52024-08-19Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin Monohydrate/MacrocrystalNITROFURANTOIN MONOHYDRATE/MACROCRYSTALDirect_Rxee13cf2a-cde0-8ab8-e053-2a95a90a9dda2024-07-30Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.6bccbaab-151b-4a04-e053-2991aa0ae1052024-06-10Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINBryant Ranch Prepackbebbe5d6-f6ec-4191-bad3-b6e933da06882024-03-15Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Sandoz Inc7ba9a729-a73a-4a13-a336-0284cc8a67e12024-02-28Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINBryant Ranch Prepack75dab97e-59b4-447c-a8c9-b4d5a970098f2024-01-04Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack05f4b126-0fb9-5ee9-c89c-f229e60f84e32023-11-09Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NorthStar RxLLCd1c778b5-70df-4312-976b-d0bca0cb602a2023-10-05Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINBryant Ranch Prepackb807bd48-71ab-4578-b1d7-4d3260bf6c752023-10-02Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINTrigen Laboratories, LLC39ffb8c6-4dd8-4436-b857-7306c15f662a2023-05-11Warnings, Adverse reactionsExact identifier
rxcui: 1648755
NitrofurantoinNITROFURANTOINProficient Rx LP34d3c103-27b8-454b-9f38-c33157c3b6fc2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin MonoNITROFURANTOIN MONOHYDRATEPharmPak, Inc.d9840719-271f-42a9-a5c9-3e039ec8fbac2022-10-09Warnings, Adverse reactionsExact identifier
rxcui: 1648755
Nitrofurantoin Monohydrate/ MacrocrystallineNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEProficient Rx LP22061f76-2c05-4501-b8dd-a5c372abe7c22022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 1648755

Reported adverse events (FAERS/openFDA)#

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