FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
82804-131
11-digit product format
828040131
Labeler code
82804
Product ID
82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-03-21
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-131-14nitrofurantoin macrocrystals14 in 1 BOTTLECAPSULE143
82804-131-20nitrofurantoin macrocrystals20 in 1 BOTTLECAPSULE203
82804-131-28nitrofurantoin macrocrystals28 in 1 BOTTLECAPSULE283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-131-14EA - Each82804-131012ce102-e233-4fea-9c1f-ab8250bab17112024-12-10
82804-131-20EA - Each82804-13100dc8e36-41a7-432b-9442-ca15fbbf912212024-08-12
82804-131-28EA - Each82804-131971b802c-2c9b-4405-bdaa-20190880074c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-131NITROFURANTOIN MACROCRYSTALS CAPSULE [PROFICIENT RX LP]3Current NDC, 3 package rows20240822_ef7053f3-3081-49c4-9c78-d40a01177fd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNef7053f3-3081-49c4-9c78-d40a01177fd93
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDef7053f3-3081-49c4-9c78-d40a01177fd93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-131-148280401311414 CAPSULE in 1 BOTTLE (82804-131-14) 14 capsule2024-07-29NoNoCurrent
82804-131-208280401312020 CAPSULE in 1 BOTTLE (82804-131-20) 20 capsule2024-07-24NoNoCurrent
82804-131-288280401312828 CAPSULE in 1 BOTTLE (82804-131-28) 28 capsule2024-07-29NoNoCurrent