FDA.reportPublic FDA data

NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE

Product NDC
52959-783
11-digit product format
529590783
Labeler code
52959
Product ID
52959-783_749b9a79-becd-5850-e053-2a91aa0a8e8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROFURANTOIN MONOHYDRATE
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA020064
Marketing category
NDA
Marketing start
2009-11-17
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],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
52959-783-002020-01-31C16284748780-19d75b9d0-e7ac-f424-e053-dadaa90a57ce0783-10,14,20,30,00
52959-783-102020-01-31C16284748780-19d75b9d0-e7ac-f424-e053-dadaa90a57ce0783-10,14,20,30,00
52959-783-142020-01-31C16284748780-19d75b9d0-e7ac-f424-e053-dadaa90a57ce0783-10,14,20,30,00
52959-783-202020-01-31C16284748780-19d75b9d0-e7ac-f424-e053-dadaa90a57ce0783-10,14,20,30,00
52959-783-302020-01-31C16284748780-19d75b9d0-e7ac-f424-e053-dadaa90a57ce0783-10,14,20,30,00

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-783-00NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE100 in 1 BOTTLECAPSULE1001
52959-783-10NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE10 in 1 BOTTLECAPSULE101
52959-783-14NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE14 in 1 BOTTLECAPSULE141
52959-783-20NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE20 in 1 BOTTLECAPSULE201
52959-783-30NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-783-00EA - Each52959-783ae7dd489-f310-46f0-88ac-5cea7df09cee12018-10-11
52959-783-10EA - Each52959-783b51e8090-c6c0-4efc-8db9-b811056a2b3112018-09-05
52959-783-14EA - Each52959-783735d1ecc-9287-4025-9184-cfe9f957b67812018-09-05
52959-783-20EA - Each52959-783620dd072-0764-466e-810f-4581054b2f7e12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-783NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE) CAPSULE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 5 package rows20180830_749b9a79-becc-5850-e053-2a91aa0a8e8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN749b9a79-becc-5850-e053-2a91aa0a8e8f1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD749b9a79-becc-5850-e053-2a91aa0a8e8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-783-0052959078300100 in 1 BOTTLEHistorical
52959-783-105295907831010 in 1 BOTTLEHistorical
52959-783-145295907831414 in 1 BOTTLEHistorical
52959-783-205295907832020 in 1 BOTTLEHistorical
52959-783-305295907833030 in 1 BOTTLEHistorical