FDA.reportPublic FDA data

Nitrofurantoin Macrocrystals

Product NDC
50268-624
11-digit product format
502680624
Labeler code
50268
Product ID
50268-624_4ba7ff07-0f36-ca5d-e063-6394a90a3357
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA073652
Marketing category
ANDA
Marketing start
2017-12-08
Substance
NITROFURANTOIN
Active strength
100 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
NITROFURANTOIN100 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
50268-624-11Nitrofurantoin Macrocrystals1 in 1 BLISTER PACKCAPSULE17
50268-624-15Nitrofurantoin Macrocrystals50 in 1 BOX, UNIT-DOSECAPSULE507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-624-11EA - Each50268-624e07102db-d147-4eba-afef-4550cbd23cab12018-03-08
50268-624-15EA - Each50268-6246dd89254-cb49-4d3f-8406-7fdfc95385ba12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-624NITROFURANTOIN 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
50268-624-11502680624111 in 1 BLISTER PACKHistorical
50268-624-155026806241550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-624-15) / 1 CAPSULE in 1 BLISTER PACK (50268-624-11) 50 blister pack2017-12-080000-00-00NoNoCurrent