Nitrofurantion Macrocrystals

Product NDC
50436-0308
11-digit product format
504360308
Labeler code
50436
Product ID
50436-0308_8658be4b-aa31-4eb7-b58d-8855aa218f3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantion Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
NDA016620
Marketing category
NDA
Marketing start
2010-09-27
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
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
50436-0308-12020-01-31C16284748780-19d75b9d1-1f08-f424-e053-dadaa90a57ceNitrofurantoin Macrocrystals Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0308-1Nitrofurantion Macrocrystals10 in 1 BOTTLECAPSULE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0308NITROFURANTION MACROCRYSTALS CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20180110_b7581146-886b-4fd3-aa64-2e6dc6832aee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNb7581146-886b-4fd3-aa64-2e6dc6832aee2
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDb7581146-886b-4fd3-aa64-2e6dc6832aee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0308-15043603080110 in 1 BOTTLEHistorical