Nitrofurantoin macrocrystals

Product NDC
40032-641
11-digit product format
400320641
Labeler code
40032
Product ID
40032-641_7372be05-1fb5-4d62-8380-6007f61c929b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA203233
Marketing category
ANDA
Marketing start
2018-07-09
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
50 mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
40032-641-012025-01-30C16284748780-12cef2736-a850-d83d-e063-dadaa90ab31fNitrofurantoin Capsules USP, (Macrocrystals)
40032-641-102025-01-30C16284748780-12cef2736-a850-d83d-e063-dadaa90ab31fNitrofurantoin Capsules USP, (Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-641-01Nitrofurantoin macrocrystals100 in 1 BOTTLECAPSULE1005
40032-641-10Nitrofurantoin macrocrystals1000 in 1 BOTTLECAPSULE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-641NITROFURANTOIN MACROCRYSTALS CAPSULE [NOVEL LABORATORIES, INC.]5Legacy NDC, 2 package rows20191221_28bb2d0e-f209-49dd-89e0-9eca473164f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN28bb2d0e-f209-49dd-89e0-9eca473164f95
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN28bb2d0e-f209-49dd-89e0-9eca473164f95
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD28bb2d0e-f209-49dd-89e0-9eca473164f95
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD28bb2d0e-f209-49dd-89e0-9eca473164f95
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY28bb2d0e-f209-49dd-89e0-9eca473164f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-641-0140032064101100 CAPSULE in 1 BOTTLE (40032-641-01) 100 capsule2018-07-090000-00-00NoNoCurrent
40032-641-10400320641101000 CAPSULE in 1 BOTTLE (40032-641-10) 1000 capsule2018-07-090000-00-00NoNoCurrent