FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
71335-2320
11-digit product format
713352320
Labeler code
71335
Product ID
71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208516
Marketing category
ANDA
Marketing start
2018-01-01
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
71335-2320-0Nitrofurantoin6 in 1 BOTTLECAPSULE6101
71335-2320-1Nitrofurantoin20 in 1 BOTTLECAPSULE20101
71335-2320-2Nitrofurantoin14 in 1 BOTTLECAPSULE14101
71335-2320-3Nitrofurantoin30 in 1 BOTTLECAPSULE30101
71335-2320-4Nitrofurantoin28 in 1 BOTTLECAPSULE28101
71335-2320-5Nitrofurantoin60 in 1 BOTTLECAPSULE60101
71335-2320-6Nitrofurantoin10 in 1 BOTTLECAPSULE10101
71335-2320-7Nitrofurantoin90 in 1 BOTTLECAPSULE90101
71335-2320-8Nitrofurantoin21 in 1 BOTTLECAPSULE21101
71335-2320-9Nitrofurantoin8 in 1 BOTTLECAPSULE8101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2320-2EA - Each71335-232033376fc9-d06d-4f31-8096-6f7a1a286f3112025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2320NITROFURANTOIN CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20250406_75dab97e-59b4-447c-a8c9-b4d5a970098f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN75dab97e-59b4-447c-a8c9-b4d5a970098f101
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD75dab97e-59b4-447c-a8c9-b4d5a970098f101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2320-0713352320006 CAPSULE in 1 BOTTLE (71335-2320-0) 6 capsule2024-01-04NoNoCurrent
71335-2320-17133523200120 CAPSULE in 1 BOTTLE (71335-2320-1) 20 capsule2024-01-04NoNoCurrent
71335-2320-27133523200214 CAPSULE in 1 BOTTLE (71335-2320-2) 14 capsule2024-01-04NoNoCurrent
71335-2320-37133523200330 CAPSULE in 1 BOTTLE (71335-2320-3) 30 capsule2024-01-04NoNoCurrent
71335-2320-47133523200428 CAPSULE in 1 BOTTLE (71335-2320-4) 28 capsule2024-01-04NoNoCurrent
71335-2320-57133523200560 CAPSULE in 1 BOTTLE (71335-2320-5) 60 capsule2024-01-04NoNoCurrent
71335-2320-67133523200610 CAPSULE in 1 BOTTLE (71335-2320-6) 10 capsule2024-01-04NoNoCurrent
71335-2320-77133523200790 CAPSULE in 1 BOTTLE (71335-2320-7) 90 capsule2024-01-04NoNoCurrent
71335-2320-87133523200821 CAPSULE in 1 BOTTLE (71335-2320-8) 21 capsule2024-01-04NoNoCurrent
71335-2320-9713352320098 CAPSULE in 1 BOTTLE (71335-2320-9) 8 capsule2024-01-04NoNoCurrent