FDA.reportPublic FDA data

NITROFURANTOIN

Product NDC
62332-391
11-digit product format
623320391
Labeler code
62332
Product ID
62332-391_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROFURANTOIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211935
Marketing category
ANDA
Marketing start
2021-07-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-391-31NITROFURANTOIN100 in 1 BOTTLECAPSULE1005
62332-391-91NITROFURANTOIN1000 in 1 BOTTLECAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-391-31EA - Each62332-3913274e50b-3dae-4b94-a262-964e1adb0d1012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-391NITROFURANTOIN CAPSULE [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20230513_a8a0d7d7-1e18-46a7-a1f8-e97499820035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNa8a0d7d7-1e18-46a7-a1f8-e974998200355
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSNa8a0d7d7-1e18-46a7-a1f8-e974998200355
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSNa8a0d7d7-1e18-46a7-a1f8-e974998200355
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDa8a0d7d7-1e18-46a7-a1f8-e974998200355
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCDa8a0d7d7-1e18-46a7-a1f8-e974998200355
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCDa8a0d7d7-1e18-46a7-a1f8-e974998200355
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSYa8a0d7d7-1e18-46a7-a1f8-e974998200355
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSYa8a0d7d7-1e18-46a7-a1f8-e974998200355
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN87505f8f-2056-4e55-adf5-5b7309081d7c2
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD87505f8f-2056-4e55-adf5-5b7309081d7c2
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN0819be0b-03e9-426e-a4b9-624c32958f941
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD0819be0b-03e9-426e-a4b9-624c32958f941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-391-3162332039131100 CAPSULE in 1 BOTTLE (62332-391-31) 100 capsule2021-07-010000-00-00NoNoCurrent
62332-391-91623320391911000 CAPSULE in 1 BOTTLE (62332-391-91) 1000 capsule2021-07-010000-00-00NoNoCurrent