nitrofurantoin macrocrystals

Product NDC
0904-7026
11-digit product format
009047026
Labeler code
0904
Product ID
0904-7026_8d3d6cd5-653a-499e-bc06-78ced2a4d334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA205005
Marketing category
ANDA
Marketing start
2018-02-15
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

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
0904-7026-61nitrofurantoin macrocrystals100 in 1 CARTONCAPSULE1007
0904-7026-61nitrofurantoin macrocrystals1 in 1 BLISTER PACKCAPSULE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7026-61EA - Each0904-7026364cfef4-4ab6-445b-a5f0-6b0eb175439912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7026NITROFURANTOIN MACROCRYSTALS CAPSULE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250330_3ee5e79f-1dca-4e1b-95a9-7859bfe344d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN3ee5e79f-1dca-4e1b-95a9-7859bfe344d17
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD3ee5e79f-1dca-4e1b-95a9-7859bfe344d17
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY3ee5e79f-1dca-4e1b-95a9-7859bfe344d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7026-6100904702661100 BLISTER PACK in 1 CARTON (0904-7026-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2018-02-150000-00-00NoNoCurrent