nitrofurantoin macrocrystals

Product NDC
72603-182
11-digit product format
726030182
Labeler code
72603
Product ID
72603-182_3dfb2c77-98f5-4810-a491-b0b0198bd9c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-12-01
Substance
NITROFURANTOIN
Active strength
25 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
NITROFURANTOIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui311994, 311995, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-182-01nitrofurantoin macrocrystals100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-182NITROFURANTOIN MACROCRYSTALS CAPSULE [NORTHSTAR RXLLC]1Current NDC, 1 package rows20231201_1e3c284a-539d-4923-a5f6-547390baf811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN1e3c284a-539d-4923-a5f6-547390baf8111
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSN1e3c284a-539d-4923-a5f6-547390baf8111
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN1e3c284a-539d-4923-a5f6-547390baf8111
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD1e3c284a-539d-4923-a5f6-547390baf8111
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCD1e3c284a-539d-4923-a5f6-547390baf8111
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD1e3c284a-539d-4923-a5f6-547390baf8111
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSY1e3c284a-539d-4923-a5f6-547390baf8111
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY1e3c284a-539d-4923-a5f6-547390baf8111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-182-0172603018201100 CAPSULE in 1 BOTTLE (72603-182-01) 100 capsule2023-12-01NoNoCurrent