FDA.reportPublic FDA data

Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
50090-4429
11-digit product format
500904429
Labeler code
50090
Product ID
50090-4429_9035f1b7-4eb4-4848-823d-2e6cb8b0ab50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA020064
Marketing category
NDA
Marketing start
2011-05-25
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
2021-12-31
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
50090-4429-02023-01-30C16284748780-1f386c649-ee1e-0266-e053-dadaa90a7c1aNitrofurantoin Monohydrate/Macrocrystals Capsules
50090-4429-12023-01-30C16284748780-1f386c649-ee1e-0266-e053-dadaa90a7c1aNitrofurantoin Monohydrate/Macrocrystals Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4429-0Nitrofurantoin Monohydrate/ Macrocrystalline14 in 1 BOTTLECAPSULE141
50090-4429-1Nitrofurantoin Monohydrate/ Macrocrystalline14 in 1 BOTTLECAPSULE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4429NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20200711_ddfebd2f-d4ae-486f-a66b-b8da9463fbf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNddfebd2f-d4ae-486f-a66b-b8da9463fbf31
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDddfebd2f-d4ae-486f-a66b-b8da9463fbf31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4429-05009044290014 CAPSULE in 1 BOTTLE (50090-4429-0) 14 capsule2019-07-190000-00-00NoNoCurrent
50090-4429-15009044290114 CAPSULE in 1 BOTTLE (50090-4429-1) 14 capsule2019-07-190000-00-00NoNoCurrent