FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
67296-1442
11-digit product format
672961442
Labeler code
67296
Product ID
67296-1442_2c6228e2-dbad-01e7-e063-6394a90acbbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug, Inc.
Application
ANDA208516
Marketing category
ANDA
Marketing start
2018-01-01
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN25 mg/1
NITROFURANTOIN MONOHYDRATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L, E1QI2CQQ1I
Rxcui1648755

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
67296-1442-12025-01-30C16284748780-12cef2736-5aac-d83d-e063-dadaa90ab31fNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1442-7Nitrofurantoin14 in 1 BOTTLECAPSULE142
67296-1442-1Nitrofurantoin10 in 1 BOTTLECAPSULE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1442NITROFURANTOIN CAPSULE [REDPHARM DRUG, INC.]2Current NDC, 1 package rows20250124_f4c2c01d-bef7-3e5d-e053-2995a90ae0d8.zip
67296-1442NITROFURANTOIN CAPSULE [REDPHARM DRUG, INC.]1Current NDC, 1 package rows20230208_f40f84ab-81b1-0f56-e053-2995a90a1d3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNf4c2c01d-bef7-3e5d-e053-2995a90ae0d82
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDf4c2c01d-bef7-3e5d-e053-2995a90ae0d82
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNf40f84ab-81b1-0f56-e053-2995a90a1d3d1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDf40f84ab-81b1-0f56-e053-2995a90a1d3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1442-16729614420110 in 1 BOTTLEHistorical
67296-1442-76729614420714 CAPSULE in 1 BOTTLE (67296-1442-7) 14 capsule2018-01-01NoNoHistorical