FDA.reportPublic FDA data

Nitrofurantion Macrocrystals

Product NDC
71205-023
11-digit product format
712050023
Labeler code
71205
Product ID
71205-023_0193ca88-0938-a229-e063-6294a90a4b38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantion Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA016620
Marketing category
NDA
Marketing start
2010-09-27
Substance
NITROFURANTOIN
Active strength
50 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
Nitrofurantion Macrocrystals
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui311995

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-023-10Nitrofurantion Macrocrystals10 in 1 BOTTLE, PLASTICCAPSULE104
71205-023-14Nitrofurantion Macrocrystals14 in 1 BOTTLE, PLASTICCAPSULE144
71205-023-20Nitrofurantion Macrocrystals20 in 1 BOTTLE, PLASTICCAPSULE204
71205-023-30Nitrofurantion Macrocrystals30 in 1 BOTTLE, PLASTICCAPSULE304
71205-023-60Nitrofurantion Macrocrystals60 in 1 BOTTLE, PLASTICCAPSULE604
71205-023-90Nitrofurantion Macrocrystals90 in 1 BOTTLE, PLASTICCAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-023-14EA - Each71205-023f38413f5-9d43-4019-bf11-be930edb3ede12018-06-11
71205-023-30EA - Each71205-023e058cf36-ed0a-40ea-bcc6-d6ba02cb65fc12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-023NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20230729_29b72c21-ab85-41de-b025-f139e6e13ccc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN29b72c21-ab85-41de-b025-f139e6e13ccc4
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD29b72c21-ab85-41de-b025-f139e6e13ccc4
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY29b72c21-ab85-41de-b025-f139e6e13ccc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-023-107120500231010 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-10) 10 capsule2018-04-020000-00-00NoNoCurrent
71205-023-147120500231414 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-14) 14 capsule2018-04-020000-00-00NoNoCurrent
71205-023-207120500232020 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-20) 20 capsule2018-04-020000-00-00NoNoCurrent
71205-023-307120500233030 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-30) 30 capsule2023-07-26NoNoHistorical
71205-023-607120500236060 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-60) 60 capsule2023-07-26NoNoHistorical
71205-023-907120500239090 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-90) 90 capsule2023-07-26NoNoHistorical