FDA.reportPublic FDA data

NITROFURANTOIN

Product NDC
46708-391
11-digit product format
467080391
Labeler code
46708
Product ID
46708-391_dacd91fc-bf3f-4ff3-a2ae-c0210796af47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROFURANTOIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-391-312023-02-01C16284748780-1f386c649-b186-0266-e053-dadaa90a7c1aNitrofurantoin Capsules, USP (Macrocrystals) Rx Only
46708-391-912023-02-01C16284748780-1f386c649-b186-0266-e053-dadaa90a7c1aNitrofurantoin Capsules, USP (Macrocrystals) Rx Only
46708-391-312023-01-30C16284748780-1f386c649-b186-0266-e053-dadaa90a7c1aNitrofurantoin Capsules, USP (Macrocrystals) Rx Only
46708-391-912023-01-30C16284748780-1f386c649-b186-0266-e053-dadaa90a7c1aNitrofurantoin Capsules, USP (Macrocrystals) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-391-31NITROFURANTOIN100 in 1 BOTTLECAPSULE1002
46708-391-91NITROFURANTOIN1000 in 1 BOTTLECAPSULE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-391NITROFURANTOIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230202_152e4fe2-7665-4725-af76-b241bd816937.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN152e4fe2-7665-4725-af76-b241bd8169372
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSN152e4fe2-7665-4725-af76-b241bd8169372
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN152e4fe2-7665-4725-af76-b241bd8169372
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD152e4fe2-7665-4725-af76-b241bd8169372
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCD152e4fe2-7665-4725-af76-b241bd8169372
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD152e4fe2-7665-4725-af76-b241bd8169372
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSY152e4fe2-7665-4725-af76-b241bd8169372
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY152e4fe2-7665-4725-af76-b241bd8169372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-391-3146708039131100 CAPSULE in 1 BOTTLE (46708-391-31) 100 capsule2021-07-010000-00-00NoNoCurrent
46708-391-91467080391911000 CAPSULE in 1 BOTTLE (46708-391-91) 1000 capsule2021-07-010000-00-00NoNoCurrent