Nitrofurantoin

Product NDC
71335-2255
11-digit product format
713352255
Labeler code
71335
Product ID
71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc
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
71335-2255-1Nitrofurantoin40 in 1 BOTTLECAPSULE40100
71335-2255-2Nitrofurantoin28 in 1 BOTTLECAPSULE28100
71335-2255-3Nitrofurantoin30 in 1 BOTTLECAPSULE30100
71335-2255-4Nitrofurantoin20 in 1 BOTTLECAPSULE20100
71335-2255-5Nitrofurantoin14 in 1 BOTTLECAPSULE14100
71335-2255-6Nitrofurantoin10 in 1 BOTTLECAPSULE10100
71335-2255-7Nitrofurantoin12 in 1 BOTTLECAPSULE12100
71335-2255-8Nitrofurantoin90 in 1 BOTTLECAPSULE90100
71335-2255-9Nitrofurantoin6 in 1 BOTTLECAPSULE6100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2255NITROFURANTOIN CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 9 package rows20231004_b807bd48-71ab-4578-b1d7-4d3260bf6c75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNb807bd48-71ab-4578-b1d7-4d3260bf6c75100
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDb807bd48-71ab-4578-b1d7-4d3260bf6c75100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2255-17133522550140 CAPSULE in 1 BOTTLE (71335-2255-1) 40 capsule2023-10-02NoNoCurrent
71335-2255-27133522550228 CAPSULE in 1 BOTTLE (71335-2255-2) 28 capsule2023-10-02NoNoCurrent
71335-2255-37133522550330 CAPSULE in 1 BOTTLE (71335-2255-3) 30 capsule2023-10-02NoNoCurrent
71335-2255-47133522550420 CAPSULE in 1 BOTTLE (71335-2255-4) 20 capsule2023-10-02NoNoCurrent
71335-2255-57133522550514 CAPSULE in 1 BOTTLE (71335-2255-5) 14 capsule2023-10-02NoNoCurrent
71335-2255-67133522550610 CAPSULE in 1 BOTTLE (71335-2255-6) 10 capsule2023-10-02NoNoCurrent
71335-2255-77133522550712 CAPSULE in 1 BOTTLE (71335-2255-7) 12 capsule2023-10-02NoNoCurrent
71335-2255-87133522550890 CAPSULE in 1 BOTTLE (71335-2255-8) 90 capsule2023-10-02NoNoCurrent
71335-2255-9713352255096 CAPSULE in 1 BOTTLE (71335-2255-9) 6 capsule2023-10-02NoNoCurrent