Nitrofurantoin

Product NDC
55700-794
11-digit product format
557000794
Labeler code
55700
Product ID
55700-794_55f7be0c-7e75-4d7e-b4fc-8fee51c3f252
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin monohydrate/macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA207372
Marketing category
ANDA
Marketing start
2019-09-27
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-794-14EA - Each55700-79476dea54e-9ae8-4bac-8100-d6866f24349312019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-794-145570007941414 CAPSULE in 1 BOTTLE (55700-794-14) 14 capsule2019-09-270000-00-00NoNoCurrent