Nitrofurantoin Macrocrystals

Product NDC
67296-2150
11-digit product format
672962150
Labeler code
67296
Product ID
67296-2150_4637d73a-84d7-0ee7-e063-6394a90aa8b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA073652
Marketing category
ANDA
Marketing start
2007-03-08
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2150-1Nitrofurantoin Macrocrystals10 in 1 BOTTLECAPSULE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2150NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG]1Current NDC, 1 package rows20250410_32520c80-0ce5-ea4b-e063-6294a90a37ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN32520c80-0ce5-ea4b-e063-6294a90a37ba4
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD32520c80-0ce5-ea4b-e063-6294a90a37ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2150-16729621500110 CAPSULE in 1 BOTTLE (67296-2150-1) 10 capsule2007-03-08NoNoHistorical