Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC
67296-0737
11-digit product format
672960737
Labeler code
67296
Product ID
67296-0737_d60cdacf-3814-4796-e053-2a95a90a3ff9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/ Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, 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
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0737-1Nitrofurantoin Monohydrate/ Macrocrystalline14 in 1 BOTTLECAPSULE146
67296-0737-2Nitrofurantoin Monohydrate/ Macrocrystalline10 in 1 BOTTLECAPSULE106
67296-0737-3Nitrofurantoin Monohydrate/ Macrocrystalline20 in 1 BOTTLECAPSULE206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0737NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE CAPSULE [REDPHARM DRUG, INC.]6Legacy NDC, 3 package rows20220121_417468df-5360-484b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN417468df-5360-484b-e054-00144ff88e886
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD417468df-5360-484b-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0737-16729607370114 CAPSULE in 1 BOTTLE (67296-0737-1) 14 capsule2011-05-250000-00-00NoNoCurrent
67296-0737-26729607370210 CAPSULE in 1 BOTTLE (67296-0737-2) 10 capsule2011-05-250000-00-00NoNoCurrent
67296-0737-36729607370320 CAPSULE in 1 BOTTLE (67296-0737-3) 20 capsule2011-05-250000-00-00NoNoCurrent