FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
51655-611
11-digit product format
516550611
Labeler code
51655
Product ID
51655-611_1359b74c-ac4a-4f16-83e0-36c8529a53a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
NDA020064
Marketing category
NDA
Marketing start
2014-07-18
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cfProduct name620251106
f6207266-e92b-4b5b-a91b-4af4215c9542Product name620240813
e31776f7-6119-9577-e170-5b569993276eProduct name520240320

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-611-022024-07-23C16284748780-19d75b9d0-1b6a-f424-e053-dadaa90a57ceNitrofurantoin Monohydrate/Macrocrystals Capsules
51655-611-842024-07-23C16284748780-19d75b9d0-1b6a-f424-e053-dadaa90a57ceNitrofurantoin Monohydrate/Macrocrystals Capsules
51655-611-022020-01-31C16284748780-19d75b9d0-1b6a-f424-e053-dadaa90a57ceNitrofurantoin Monohydrate/Macrocrystals Capsules
51655-611-842020-01-31C16284748780-19d75b9d0-1b6a-f424-e053-dadaa90a57ceNitrofurantoin Monohydrate/Macrocrystals Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-611-02Nitrofurantoin Monohydrate/Macrocrystals2 in 1 BOTTLE, DISPENSINGCAPSULE22
51655-611-20Nitrofurantoin Monohydrate/Macrocrystals20 in 1 BOTTLE, PLASTICCAPSULE202
51655-611-53Nitrofurantoin Monohydrate/Macrocrystals10 in 1 BOTTLE, PLASTICCAPSULE102
51655-611-84Nitrofurantoin Monohydrate/Macrocrystals14 in 1 BOTTLE, DISPENSINGCAPSULE142

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1INITROFURANTOIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-611NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC, 4 package rows20240724_b044add2-528b-47ad-a934-63789c7268f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNb044add2-528b-47ad-a934-63789c7268f12
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDb044add2-528b-47ad-a934-63789c7268f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51655-611-02516550611022 in 1 BOTTLE, DISPENSINGHistorical
51655-611-205165506112020 in 1 BOTTLE, PLASTICHistorical
51655-611-535165506115310 in 1 BOTTLE, PLASTICHistorical
51655-611-845165506118414 in 1 BOTTLE, DISPENSINGHistorical