FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
82868-015
11-digit product format
828680015
Labeler code
82868
Product ID
82868-015_46dc9595-3ec6-a1ad-e063-6394a90a3d15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-10-06
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], 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 macrocrystals
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui1648759

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82868-015-10nitrofurantoin macrocrystals10 in 1 BOTTLE, PLASTICCAPSULE105
82868-015-14nitrofurantoin macrocrystals14 in 1 BOTTLE, PLASTICCAPSULE145
82868-015-20nitrofurantoin macrocrystals20 in 1 BOTTLE, PLASTICCAPSULE205
82868-015-28nitrofurantoin macrocrystals28 in 1 BOTTLE, PLASTICCAPSULE285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-015NITROFURANTOIN MACROCRYSTALS CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, 4 package rows20240814_075fe819-fc4f-2dce-e063-6294a90ad823.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN075fe819-fc4f-2dce-e063-6294a90ad8235
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD075fe819-fc4f-2dce-e063-6294a90ad8235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-015-108286800151010 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-10) 10 capsule2024-02-08NoNoHistorical
82868-015-148286800151414 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-14) 14 capsule2023-10-06NoNoHistorical
82868-015-208286800152020 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-20) 20 capsule2024-06-04NoNoHistorical
82868-015-288286800152828 CAPSULE in 1 BOTTLE, PLASTIC (82868-015-28) 28 capsule2024-07-29NoNoHistorical