FDA.reportPublic FDA data

NITROFURANTOIN

Product NDC
65862-929
11-digit product format
658620929
Labeler code
65862
Product ID
65862-929_33dc19bb-994d-4aad-a4b7-6697c1d8811b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (Monohydrate/Macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209225
Marketing category
ANDA
Marketing start
2023-03-30
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
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/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
65862-929-01NITROFURANTOIN100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-929-01EA - Each65862-92902917b1c-a749-4a4c-9251-5ad90e45860a12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-929NITROFURANTOIN (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)) CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, 1 package rows20241220_788f1fe3-d8a1-42cc-9280-07f842da34ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN8450fee6-7b9d-4c74-848e-c4f42c1963f9100
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD8450fee6-7b9d-4c74-848e-c4f42c1963f9100
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN788f1fe3-d8a1-42cc-9280-07f842da34ea2
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD788f1fe3-d8a1-42cc-9280-07f842da34ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65862-929-0165862092901100 CAPSULE in 1 BOTTLE (65862-929-01) 100 capsule2023-03-30NoNoHistorical