Nitrofurantoin

Product NDC
50090-4570
11-digit product format
500904570
Labeler code
50090
Product ID
50090-4570_9ae1724f-4959-4be9-8a4f-6c0fbb2a939e
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4570-0Nitrofurantoin(monohydrate/macrocrystals)14 in 1 BOTTLECAPSULE143
50090-4570-2Nitrofurantoin(monohydrate/macrocrystals)6 in 1 BOTTLECAPSULE63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4570NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f3
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4570-05009045700014 CAPSULE in 1 BOTTLE (50090-4570-0) 14 capsule2019-09-270000-00-00NoNoCurrent
50090-4570-2500904570026 CAPSULE in 1 BOTTLE (50090-4570-2) 6 capsule2019-09-270000-00-00NoNoCurrent