FDA.reportPublic FDA data

Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
68071-4367
11-digit product format
680714367
Labeler code
68071
Product ID
68071-4367_2a81d529-e3bd-721c-e063-6394a90a0222
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
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 (monohydrate/macrocrystals)
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4367-22023-02-22C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42023-02-22C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-22023-01-30C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42023-01-30C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-22021-02-16C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42021-02-16C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-22021-01-29C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4367-42021-01-29C16284748780-1ba0f9c33-1e02-a910-e053-dadaa90a0b85Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4367-1Nitrofurantoin (monohydrate/macrocrystals)10 in 1 BOTTLECAPSULE106
68071-4367-2Nitrofurantoin (monohydrate/macrocrystals)20 in 1 BOTTLECAPSULE206
68071-4367-4Nitrofurantoin (monohydrate/macrocrystals)14 in 1 BOTTLECAPSULE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4367NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20250101_68a651f9-1aef-792e-e053-2991aa0a3cbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN68a651f9-1aef-792e-e053-2991aa0a3cbb6
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD68a651f9-1aef-792e-e053-2991aa0a3cbb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4367-16807143670110 CAPSULE in 1 BOTTLE (68071-4367-1) 10 capsule2018-03-30NoNoCurrent
68071-4367-26807143670220 CAPSULE in 1 BOTTLE (68071-4367-2) 20 capsule2018-03-300000-00-00NoNoCurrent
68071-4367-46807143670414 CAPSULE in 1 BOTTLE (68071-4367-4) 14 capsule2018-03-300000-00-00NoNoCurrent