Nizatidine

Product NDC
65162-659
11-digit product format
651620659
Labeler code
65162
Product ID
65162-659_9d0a7b73-b495-419d-b941-2395109eab3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nizatidine
Dosage form
SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA090576
Marketing category
ANDA
Marketing start
2009-12-14
Marketing end
2022-10-31
Substance
NIZATIDINE
Active strength
15 mg/mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-659-90ML - Milliliter65162-6598f6d488b-3972-4d5d-a806-cebae038c9f112012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-659-9065162065990480 mL in 1 BOTTLE (65162-659-90) 480 ml2009-12-140000-00-00NoNoCurrent