Nitrofurantion Macrocrystals

Product NDC
12634-415
11-digit product format
126340415
Labeler code
12634
Product ID
12634-415_27fa784f-085a-0b97-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantion Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotheca Inc.
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
12634-415-002020-01-31C16284748780-19d75b9d0-d804-f424-e053-dadaa90a57ceNitrofurantoin Macrocrystals Capsules
12634-415-842020-01-31C16284748780-19d75b9d0-d804-f424-e053-dadaa90a57ceNitrofurantoin Macrocrystals Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-415-00Nitrofurantion Macrocrystals10 in 1 BOTTLECAPSULE101
12634-415-84Nitrofurantion Macrocrystals14 in 1 BOTTLECAPSULE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-415NITROFURANTION MACROCRYSTALS CAPSULE [APOTHECA INC.]1Legacy NDC, 2 package rows20151228_27fa784f-0859-0b97-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN27fa784f-0859-0b97-e054-00144ff8d46c1
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD27fa784f-0859-0b97-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-415-001263404150010 in 1 BOTTLEHistorical
12634-415-841263404158414 in 1 BOTTLEHistorical