FDA.reportPublic FDA data

NITROFURANTOIN MACROCRYSTALS

Product NDC
61919-458
11-digit product format
619190458
Labeler code
61919
Product ID
61919-458_f214178a-081e-957e-e053-2995a90a828e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
NDA016620
Marketing category
NDA
Marketing start
2018-02-28
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-458-022025-01-30C16284748780-12cef2736-963b-d83d-e063-dadaa90ab31fNITROFURANTOIN MACROCRYSTALS
61919-458-142025-01-30C16284748780-12cef2736-963b-d83d-e063-dadaa90ab31fNITROFURANTOIN MACROCRYSTALS
61919-458-202025-01-30C16284748780-12cef2736-963b-d83d-e063-dadaa90ab31fNITROFURANTOIN MACROCRYSTALS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-458-02NITROFURANTOIN MACROCRYSTALS2 in 1 BOTTLECAPSULE23
61919-458-14NITROFURANTOIN MACROCRYSTALS14 in 1 BOTTLECAPSULE143
61919-458-20NITROFURANTOIN MACROCRYSTALS20 in 1 BOTTLECAPSULE203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-458-02EA - Each61919-45870ba8c00-a4ee-46d4-bede-c63178c5dd3c12019-11-12
61919-458-14EA - Each61919-45856969d80-ed18-4104-aa1d-5472d51cc41912019-11-12
61919-458-20EA - Each61919-4585f1699be-d6e8-4ba4-a2f7-eff10421be6312018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-458NITROFURANTOIN MACROCRYSTALS (NITROFURANTOIN) CAPSULE [DIRECT RX]3Legacy NDC, 3 package rows20230113_66474d1d-afc8-f611-e053-2a91aa0acbf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN66474d1d-afc8-f611-e053-2a91aa0acbf53
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD66474d1d-afc8-f611-e053-2a91aa0acbf53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-458-02619190458022 CAPSULE in 1 BOTTLE (61919-458-02) 2 capsule2018-02-280000-00-00NoNoCurrent
61919-458-146191904581414 CAPSULE in 1 BOTTLE (61919-458-14) 14 capsule2018-02-280000-00-00NoNoCurrent
61919-458-206191904582020 CAPSULE in 1 BOTTLE (61919-458-20) 20 capsule2018-02-280000-00-00NoNoCurrent