FDA.reportPublic FDA data

NITROFURANTOIN (monohydrate/macrocrystals)

Product NDC
42708-184
11-digit product format
427080184
Labeler code
42708
Product ID
42708-184_4586f98c-081a-3d32-e063-6394a90aeb5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
QPharma, Inc.
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NITROFURANTOIN (monohydrate/macrocrystals)
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-184-14NITROFURANTOIN (monohydrate/macrocrystals)14 in 1 BOTTLE, PLASTICCAPSULE145
42708-184-28NITROFURANTOIN (monohydrate/macrocrystals)28 in 1 BOTTLE, PLASTICCAPSULE285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-184NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [QPHARMA, INC.]3Current NDC, 2 package rows20250521_055477be-e42c-fe8b-e063-6394a90a0449.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN055477be-e42c-fe8b-e063-6394a90a04495
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD055477be-e42c-fe8b-e063-6394a90a04495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42708-184-144270801841414 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-14) 14 capsule2025-10-17YesNoHistorical
42708-184-284270801842828 CAPSULE in 1 BOTTLE, PLASTIC (42708-184-28) 28 capsule2023-09-22YesNoHistorical