Nitrofurantoin

Product NDC
50090-4591
11-digit product format
500904591
Labeler code
50090
Product ID
50090-4591_0a618fb0-ed47-4198-baef-e83e005251aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin monohydrate/macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207372
Marketing category
ANDA
Marketing start
2017-05-25
Marketing end
0000-00-00
Substance
NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength
75 mg/1; mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4591-12023-01-30C16284748780-1f386c64a-288f-0266-e053-dadaa90a7c1aNitrofurantoin Capsules, USP (monohydrate/macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4591-1Nitrofurantoin(monohydrate/macrocrystals)10 in 1 BOTTLECAPSULE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4591-1EA - Each50090-4591e3ed0bce-1f56-4870-97f7-e534e4e76fd512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4591NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210803_2bedff75-22c8-49cf-b2e6-8471fd69055c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN2bedff75-22c8-49cf-b2e6-8471fd69055c3
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD2bedff75-22c8-49cf-b2e6-8471fd69055c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4591-15009045910110 CAPSULE in 1 BOTTLE (50090-4591-1) 10 capsule2020-04-150000-00-00NoNoCurrent