FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
71335-2212
11-digit product format
713352212
Labeler code
71335
Product ID
71335-2212_286e68d4-754d-4900-9365-901ecccac6b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-03-21
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2212-1nitrofurantoin macrocrystals40 in 1 BOTTLECAPSULE40100
71335-2212-2nitrofurantoin macrocrystals28 in 1 BOTTLECAPSULE28100
71335-2212-3nitrofurantoin macrocrystals30 in 1 BOTTLECAPSULE30100
71335-2212-4nitrofurantoin macrocrystals20 in 1 BOTTLECAPSULE20100
71335-2212-5nitrofurantoin macrocrystals14 in 1 BOTTLECAPSULE14100
71335-2212-6nitrofurantoin macrocrystals10 in 1 BOTTLECAPSULE10100
71335-2212-7nitrofurantoin macrocrystals12 in 1 BOTTLECAPSULE12100
71335-2212-8nitrofurantoin macrocrystals90 in 1 BOTTLECAPSULE90100
71335-2212-9nitrofurantoin macrocrystals6 in 1 BOTTLECAPSULE6100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2212-6EA - Each71335-22129b00a1c3-b3a1-49f0-8b35-7bcbbe5de72b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2212NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 9 package rows20230824_4bac93c7-dd35-4f5a-8067-5c6fcccc729d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN4bac93c7-dd35-4f5a-8067-5c6fcccc729d100
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD4bac93c7-dd35-4f5a-8067-5c6fcccc729d100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2212-17133522120140 CAPSULE in 1 BOTTLE (71335-2212-1) 40 capsule2023-08-15NoNoCurrent
71335-2212-27133522120228 CAPSULE in 1 BOTTLE (71335-2212-2) 28 capsule2023-08-15NoNoCurrent
71335-2212-37133522120330 CAPSULE in 1 BOTTLE (71335-2212-3) 30 capsule2023-08-15NoNoCurrent
71335-2212-47133522120420 CAPSULE in 1 BOTTLE (71335-2212-4) 20 capsule2023-08-15NoNoCurrent
71335-2212-57133522120514 CAPSULE in 1 BOTTLE (71335-2212-5) 14 capsule2023-08-15NoNoCurrent
71335-2212-67133522120610 CAPSULE in 1 BOTTLE (71335-2212-6) 10 capsule2023-08-15NoNoCurrent
71335-2212-77133522120712 CAPSULE in 1 BOTTLE (71335-2212-7) 12 capsule2023-08-15NoNoCurrent
71335-2212-87133522120890 CAPSULE in 1 BOTTLE (71335-2212-8) 90 capsule2023-08-15NoNoCurrent
71335-2212-9713352212096 CAPSULE in 1 BOTTLE (71335-2212-9) 6 capsule2023-08-15NoNoCurrent