FDA.reportPublic FDA data

NITROFURANTOIN

Product NDC
72189-179
11-digit product format
721890179
Labeler code
72189
Product ID
72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROFURANTOIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Directrx
Application
ANDA077066
Marketing category
ANDA
Marketing start
2022-01-18
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
72189-179-10NITROFURANTOIN10 in 1 BOTTLECAPSULE104
72189-179-14NITROFURANTOIN14 in 1 BOTTLECAPSULE144
72189-179-20NITROFURANTOIN20 in 1 BOTTLECAPSULE204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-179-10EA - Each72189-179db628722-3061-41a2-ad38-95e6f8bc666a12022-11-07
72189-179-14EA - Each72189-17956ee474b-7ae2-40dc-804a-a7ec4bcedc9512022-02-07
72189-179-20EA - Each72189-17978508fe2-d9c8-40f0-bbb2-b05bdbd4d74812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-179NITROFURANTOIN CAPSULE [DIRECTRX]4Current NDC, Legacy NDC, 3 package rows20250119_d4385368-46d6-8397-e053-2a95a90a8d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNd4385368-46d6-8397-e053-2a95a90a8d684
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDd4385368-46d6-8397-e053-2a95a90a8d684

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-179-107218901791010 CAPSULE in 1 BOTTLE (72189-179-10) 10 capsule2022-01-180000-00-00NoNoCurrent
72189-179-147218901791414 CAPSULE in 1 BOTTLE (72189-179-14) 14 capsule2022-01-180000-00-00NoNoCurrent
72189-179-207218901792020 CAPSULE in 1 BOTTLE (72189-179-20) 20 capsule2022-01-180000-00-00NoNoCurrent