FDA.reportPublic FDA data

NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE

Product NDC
61919-021
11-digit product format
619190021
Labeler code
61919
Product ID
61919-021_397f7645-278c-731e-e063-6294a90a2d3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROFURANTOIN MONOHYDRATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
NDA020064
Marketing category
NDA
Marketing start
2019-07-08
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 MACROCRYSTALLINE
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
61919-021-202024-01-30C16284748780-19d75b9cf-fdf4-f424-e053-dadaa90a57ceNITRO/MONO/MACRO 100mg
61919-021-202020-12-14C16284748780-19d75b9cf-fdf4-f424-e053-dadaa90a57ceNITRO/MONO/MACRO 100mg
61919-021-202020-01-31C16284748780-19d75b9cf-fdf4-f424-e053-dadaa90a57ceNITRO/MONO/MACRO 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-021-02NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE2 in 1 BOTTLECAPSULE28
61919-021-10NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE10 in 1 BOTTLECAPSULE108
61919-021-14NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE14 in 1 BOTTLECAPSULE148
61919-021-20NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE20 in 1 BOTTLECAPSULE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-021-02EA - Each61919-02105d47e6c-9e9f-4391-870d-7dfbfd351b9d12019-10-07
61919-021-10EA - Each61919-021d178b562-803e-4a7d-9dbc-abe4b3852fd812025-05-14
61919-021-14EA - Each61919-021cbe4ed94-940c-46f3-95f6-27fa06e7173f12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE) CAPSULE [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20201215_4882de1c-7b69-060d-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN8d2e456a-ffb2-3f1e-e053-2995a90a22df8
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD8d2e456a-ffb2-3f1e-e053-2995a90a22df8
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN4882de1c-7b69-060d-e054-00144ff8d46c2
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD4882de1c-7b69-060d-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-021-02619190021022 CAPSULE in 1 BOTTLE (61919-021-02) 2 capsule2019-07-080000-00-00NoNoCurrent
61919-021-106191900211010 CAPSULE in 1 BOTTLE (61919-021-10) 10 capsule2019-07-08NoNoHistorical
61919-021-146191900211414 CAPSULE in 1 BOTTLE (61919-021-14) 14 capsule2019-07-080000-00-00NoNoCurrent
61919-021-206191900212020 CAPSULE in 1 BOTTLE (61919-021-20) 20 capsule2017-02-140000-00-00NoNoCurrent