FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
43386-450
11-digit product format
433860450
Labeler code
43386
Product ID
43386-450_361dd255-19ba-453f-9b68-ade3185ff390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA201693
Marketing category
ANDA
Marketing start
2015-05-21
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
43386-450-11Nitrofurantoin230 mL in 1 BOTTLESUSPENSION2303
43386-450-11Nitrofurantoin1 in 1 CARTONSUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-450-11ML - Milliliter43386-450410b0045-72c8-4823-b9ca-9ae71625e19c12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-450NITROFURANTOIN SUSPENSION [LUPIN PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20230625_93c37857-38f1-4e2e-acb8-4846840e3e85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311989nitrofurantoin 25 MG in 5 mL Oral SuspensionPSN93c37857-38f1-4e2e-acb8-4846840e3e853
311989nitrofurantoin 5 MG/ML Oral SuspensionSCD93c37857-38f1-4e2e-acb8-4846840e3e853
311989nitrofurantoin 25 MG per 5 ML Oral SuspensionSY93c37857-38f1-4e2e-acb8-4846840e3e853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-450-11433860450111 BOTTLE in 1 CARTON (43386-450-11) / 230 mL in 1 BOTTLE1 bottle2015-05-210000-00-00NoNoCurrent