FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
40032-450
11-digit product format
400320450
Labeler code
40032
Product ID
40032-450_f62f5875-c0f1-4892-95c4-a811d8b6f1de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA201693
Marketing category
ANDA
Marketing start
2014-09-08
Substance
NITROFURANTOIN
Active strength
25 mg/5mL
Pharmacologic classes
Nitrofuran Antibacterial [EPC], 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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui311989

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-450-11Nitrofurantoin1 in 1 CARTONSUSPENSION15
40032-450-11Nitrofurantoin230 mL in 1 BOTTLESUSPENSION2305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RNITROFURANTOIN ORAL SUSPENSION (NITROFURANTOIN) SUSPENSION [NOVEL LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-450NITROFURANTOIN SUSPENSION [NOVEL LABORATORIES, INC.]5Current NDC, Legacy NDC, 2 package rows20161117_499f9dfd-b533-4021-a3ed-308f0f956c79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311989nitrofurantoin 25 MG in 5 mL Oral SuspensionPSN499f9dfd-b533-4021-a3ed-308f0f956c795
311989nitrofurantoin 5 MG/ML Oral SuspensionSCD499f9dfd-b533-4021-a3ed-308f0f956c795
311989nitrofurantoin 25 MG per 5 ML Oral SuspensionSY499f9dfd-b533-4021-a3ed-308f0f956c795

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-450-11400320450111 BOTTLE in 1 CARTON (40032-450-11) / 230 mL in 1 BOTTLE1 bottle2014-09-080000-00-00NoNoCurrent