LANSOPRAZOLE

Product NDC
16571-697
11-digit product format
165710697
Labeler code
16571
Product ID
16571-697_348119f9-610e-46f1-affa-f9e68959b2f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANSOPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA201921
Marketing category
ANDA
Marketing start
2020-11-01
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-697-03EA - Each16571-6974062cfe2-0be2-4079-a6f6-cdabb0b8b47212021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-697LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]2Legacy NDC20231103_348119f9-610e-46f1-affa-f9e68959b2f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-697-031657106970330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-03) 2020-11-010000-00-00NoNoCurrent
16571-697-5016571069750500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-50) 2020-11-010000-00-00NoNoCurrent