FDA.reportPublic FDA data

nitrofurantoin

Product NDC
50090-7217
11-digit product format
500907217
Labeler code
50090
Product ID
50090-7217_bb60450d-7bb5-434e-b1d5-23d653a1c2fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-12-01
Substance
NITROFURANTOIN
Active strength
100 mg/1
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
NITROFURANTOIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui1648759

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7217-0nitrofurantoin28 in 1 BOTTLECAPSULE281
50090-7217-2nitrofurantoin20 in 1 BOTTLECAPSULE201
50090-7217-3nitrofurantoin14 in 1 BOTTLECAPSULE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7217-0EA - Each50090-72179eccb0bf-4bc9-48ae-b446-164b533dd9a512024-09-09
50090-7217-2EA - Each50090-72170690765e-fcec-41c9-a065-f5109e1e673912024-09-09
50090-7217-3EA - Each50090-72177a6c4380-d4f8-49b9-b855-67f0b918c35b12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7217NITROFURANTOIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20240816_4cd9e234-a2b9-4201-b8f8-cf37c0672de7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN4cd9e234-a2b9-4201-b8f8-cf37c0672de71
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD4cd9e234-a2b9-4201-b8f8-cf37c0672de71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7217-05009072170028 CAPSULE in 1 BOTTLE (50090-7217-0) 28 capsule2024-08-12NoNoCurrent
50090-7217-25009072170220 CAPSULE in 1 BOTTLE (50090-7217-2) 20 capsule2024-08-12NoNoCurrent
50090-7217-35009072170314 CAPSULE in 1 BOTTLE (50090-7217-3) 14 capsule2024-08-12NoNoCurrent