Nitrofurantoin

Product NDC
16571-740
11-digit product format
165710740
Labeler code
16571
Product ID
16571-740_c2913006-9e6a-4ec6-9bbe-b160eb0612d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
NDA009175
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-12-23
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
25 mg/5mL
Pharmacologic classes
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-740-24Nitrofurantoin1 in 1 CARTONSUSPENSION15
16571-740-24Nitrofurantoin230 mL in 1 BOTTLESUSPENSION2305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-740-24ML - Milliliter16571-740691716cd-a66c-40af-a82a-acc419a90e3412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-740NITROFURANTOIN SUSPENSION [RISING PHARMA HOLDINGS, INC.]4Legacy NDC, 2 package rows20240406_89095f4d-e142-465e-b378-da24f6eeaf2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311989nitrofurantoin 25 MG in 5 mL Oral SuspensionPSN89095f4d-e142-465e-b378-da24f6eeaf2b5
422434nitrofurantoin 50 MG in 5 mL Oral SuspensionPSN89095f4d-e142-465e-b378-da24f6eeaf2b5
422434nitrofurantoin 10 MG/ML Oral SuspensionSCD89095f4d-e142-465e-b378-da24f6eeaf2b5
311989nitrofurantoin 5 MG/ML Oral SuspensionSCD89095f4d-e142-465e-b378-da24f6eeaf2b5
311989nitrofurantoin 25 MG per 5 ML Oral SuspensionSY89095f4d-e142-465e-b378-da24f6eeaf2b5
422434nitrofurantoin 50 MG per 5 ML Oral SuspensionSY89095f4d-e142-465e-b378-da24f6eeaf2b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-740-24165710740241 BOTTLE in 1 CARTON (16571-740-24) > 230 mL in 1 BOTTLE1 bottle2020-12-230000-00-00NoNoCurrent