FDA.reportPublic FDA data

nitrofurantoin (macrocrystals)

Product NDC
50090-7308
11-digit product format
500907308
Labeler code
50090
Product ID
50090-7308_b0e07675-526a-4083-a35e-2a93ad10888b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin (macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077025
Marketing category
ANDA
Marketing start
2023-05-17
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 (macrocrystals)
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
50090-7308-0nitrofurantoin (macrocrystals)28 in 1 BOTTLECAPSULE281
50090-7308-2nitrofurantoin (macrocrystals)20 in 1 BOTTLECAPSULE201
50090-7308-3nitrofurantoin (macrocrystals)14 in 1 BOTTLECAPSULE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7308-0EA - Each50090-73088ed8870a-d6c7-4a36-aaff-d3558c6b60f812024-11-05
50090-7308-2EA - Each50090-7308d440fc68-f06e-4fd3-b25c-de5731d1da8512024-11-05
50090-7308-3EA - Each50090-7308ad0bccc3-d0a1-45d0-933b-8ab7b4523f4212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7308NITROFURANTOIN (MACROCRYSTALS) CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241017_bc90b22e-e48a-4a22-b328-ca5bb2561864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNbc90b22e-e48a-4a22-b328-ca5bb25618641
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDbc90b22e-e48a-4a22-b328-ca5bb25618641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7308-05009073080028 CAPSULE in 1 BOTTLE (50090-7308-0) 28 capsule2024-10-14NoNoCurrent
50090-7308-25009073080220 CAPSULE in 1 BOTTLE (50090-7308-2) 20 capsule2024-10-14NoNoCurrent
50090-7308-35009073080314 CAPSULE in 1 BOTTLE (50090-7308-3) 14 capsule2024-10-14NoNoCurrent