FDA.reportPublic FDA data

Nitrofurantoin Macrocrystals

Product NDC
50268-623
11-digit product format
502680623
Labeler code
50268
Product ID
50268-623_4ba7ff07-0f36-ca5d-e063-6394a90a3357
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA073671
Marketing category
ANDA
Marketing start
2017-12-08
Substance
NITROFURANTOIN
Active strength
50 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin Macrocrystals
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui311995, 1648759

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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-623-11Nitrofurantoin Macrocrystals1 in 1 BLISTER PACKCAPSULE17
50268-623-15Nitrofurantoin Macrocrystals50 in 1 BOX, UNIT-DOSECAPSULE507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-623-11EA - Each50268-6236e40dcb1-1d56-4cd7-995a-9ee5fa95d3d112019-11-12
50268-623-15EA - Each50268-623f96c0055-a7b8-4f04-8353-20dd1645d22b12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-623NITROFURANTOIN MACROCRYSTALS CAPSULE [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_650f3c60-d45d-4358-a388-7efee4ad0497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN650f3c60-d45d-4358-a388-7efee4ad04977
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN650f3c60-d45d-4358-a388-7efee4ad04977
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD650f3c60-d45d-4358-a388-7efee4ad04977
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD650f3c60-d45d-4358-a388-7efee4ad04977
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY650f3c60-d45d-4358-a388-7efee4ad04977

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-623-11502680623111 in 1 BLISTER PACKHistorical
50268-623-155026806231550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-623-15) / 1 CAPSULE in 1 BLISTER PACK (50268-623-11) 50 blister pack2017-12-080000-00-00NoNoCurrent