FDA.reportPublic FDA data

NITROFURANTOIN

Product NDC
50090-6664
11-digit product format
500906664
Labeler code
50090
Product ID
50090-6664_41c1cb5c-46d8-41d0-8996-89061fa5c058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211013
Marketing category
ANDA
Marketing start
2022-02-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NITROFURANTOIN
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6664-0NITROFURANTOIN14 in 1 BOTTLECAPSULE143
50090-6664-1NITROFURANTOIN10 in 1 BOTTLECAPSULE103
50090-6664-2NITROFURANTOIN6 in 1 BOTTLECAPSULE63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6664-0EA - Each50090-6664266ff9b9-d3af-48b6-b3d4-e42868d42de812023-10-16
50090-6664-1EA - Each50090-6664c1cd2c2e-dfcf-44b8-ab0e-be7382daa23712023-10-16
50090-6664-2EA - Each50090-6664f63e46e8-8585-4ce7-9c96-fcab543dd82812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6664NITROFURANTOIN (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)) CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230906_b6c5bbb0-86db-4a76-a1eb-98573a0b0adc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNb6c5bbb0-86db-4a76-a1eb-98573a0b0adc3
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDb6c5bbb0-86db-4a76-a1eb-98573a0b0adc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6664-05009066640014 CAPSULE in 1 BOTTLE (50090-6664-0) 14 capsule2023-08-30NoNoHistorical
50090-6664-15009066640110 CAPSULE in 1 BOTTLE (50090-6664-1) 10 capsule2023-08-30NoNoHistorical
50090-6664-2500906664026 CAPSULE in 1 BOTTLE (50090-6664-2) 6 capsule2023-08-30NoNoHistorical