Nitrofurantoin

Product NDC
0115-2024
11-digit product format
001152024
Labeler code
0115
Product ID
0115-2024_02cea479-7d68-4d65-9d78-9529e02453c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA091095
Marketing category
ANDA
Marketing start
2015-10-01
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
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
0115-2024-102023-01-30C16284748780-1f386c649-a42e-0266-e053-dadaa90a7c1aNitrofurantoin Capsules USP (Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-2024-10Nitrofurantoin100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-2024NITROFURANTOIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]2Legacy NDC, 1 package rows20201022_acd6608c-66de-4f17-9fd1-d408e388b764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNacd6608c-66de-4f17-9fd1-d408e388b7642
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSNacd6608c-66de-4f17-9fd1-d408e388b7642
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDacd6608c-66de-4f17-9fd1-d408e388b7642
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCDacd6608c-66de-4f17-9fd1-d408e388b7642
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSYacd6608c-66de-4f17-9fd1-d408e388b7642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-2024-1000115202410100 CAPSULE in 1 BOTTLE (0115-2024-10) 100 capsule2015-10-010000-00-00NoNoCurrent