FDA.reportPublic FDA data

Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
68071-4428
11-digit product format
680714428
Labeler code
68071
Product ID
68071-4428_1a8c366e-d568-fc06-e063-6394a90abec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077066
Marketing category
ANDA
Marketing start
2005-04-06
Marketing end
2027-03-18
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin (monohydrate/macrocrystals)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4428-22023-03-10C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-62023-03-10C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-22023-01-30C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-62023-01-30C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-22020-02-18C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-62020-02-18C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-22020-01-31C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-62020-01-31C16284748780-19d75b9d0-24eb-f424-e053-dadaa90a57ceNitrofurantoin Capsules USP (Monohydrate/Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4428-2Nitrofurantoin (monohydrate/macrocrystals)2 in 1 BOTTLECAPSULE25
68071-4428-6Nitrofurantoin (monohydrate/macrocrystals)6 in 1 BOTTLECAPSULE65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4428NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20240710_6bccbaab-151b-4a04-e053-2991aa0ae105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN6bccbaab-151b-4a04-e053-2991aa0ae1055
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD6bccbaab-151b-4a04-e053-2991aa0ae1055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4428-2680714428022 CAPSULE in 1 BOTTLE (68071-4428-2) 2 capsule2018-05-092027-03-18NoNoCurrent
68071-4428-6680714428066 CAPSULE in 1 BOTTLE (68071-4428-6) 6 capsule2018-05-092027-03-18NoNoCurrent