FDA.reportPublic FDA data

Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
68071-2575
11-digit product format
680712575
Labeler code
68071
Product ID
68071-2575_d0d93807-1d7a-5538-e053-2a95a90ac237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA020064
Marketing category
NDA
Marketing start
2011-05-25
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
2022-12-31
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
68071-2575-22025-01-30C16284748780-1f386c649-ec79-0266-e053-dadaa90a7c1aNitrofurantoin Monohydrate/Macrocrystals Capsules
68071-2575-22023-06-07C16284748780-1f386c649-ec79-0266-e053-dadaa90a7c1aNitrofurantoin Monohydrate/Macrocrystals Capsules
68071-2575-22023-01-30C16284748780-1f386c649-ec79-0266-e053-dadaa90a7c1aNitrofurantoin Monohydrate/Macrocrystals Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2575-2Nitrofurantoin Monohydrate/ Macrocrystalline2 in 1 BOTTLECAPSULE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2575NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 1 package rows20230718_d0d93807-1d7b-5538-e053-2a95a90ac237.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNd0d93807-1d7b-5538-e053-2a95a90ac2373
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDd0d93807-1d7b-5538-e053-2a95a90ac2373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2575-2680712575022 CAPSULE in 1 BOTTLE (68071-2575-2) 2 capsule2021-11-150000-00-00NoNoCurrent