Nizatidine

Product NDC
68462-426
11-digit product format
684620426
Labeler code
68462
Product ID
68462-426_d5f77199-a705-41d7-a283-c2d8e4a4ea57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nizatidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090618
Marketing category
ANDA
Marketing start
2011-07-15
Marketing end
0000-00-00
Substance
NIZATIDINE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-426-30EA - Each68462-426ea336e0a-cdbb-4157-b8a3-04dc99b7427212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-426-0168462042601100 CAPSULE in 1 BOTTLE (68462-426-01) 100 capsule2011-07-150000-00-00NoNoCurrent
68462-426-306846204263030 CAPSULE in 1 BOTTLE (68462-426-30) 30 capsule2011-07-150000-00-00NoNoCurrent