FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
68071-3569
11-digit product format
680713569
Labeler code
68071
Product ID
68071-3569_127807d8-587d-49c7-e063-6294a90a0e43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA217357
Marketing category
ANDA
Marketing start
2023-09-14
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], 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
NITROFURANTOIN25 mg/1
NITROFURANTOIN MONOHYDRATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L, E1QI2CQQ1I
Rxcui1648755

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
68071-3569-2Nitrofurantoin20 in 1 BOTTLECAPSULE202
68071-3569-4Nitrofurantoin14 in 1 BOTTLECAPSULE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3569NITROFURANTOIN (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)) CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20240301_10e2503d-a250-996f-e063-6294a90abd61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN10e2503d-a250-996f-e063-6294a90abd612
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD10e2503d-a250-996f-e063-6294a90abd612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3569-26807135690220 CAPSULE in 1 BOTTLE (68071-3569-2) 20 capsule2024-02-08NoNoHistorical
68071-3569-46807135690414 CAPSULE in 1 BOTTLE (68071-3569-4) 14 capsule2024-02-08NoNoHistorical