Lansoprazole

Product NDC
50090-6830
11-digit product format
500906830
Labeler code
50090
Product ID
50090-6830_bcea941c-d404-4e4d-9ea9-028efb0355d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
50090-6830_bcea941c-d404-4e4d-9ea9-028efb0355d7
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Lansoprazole
Generic name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing start
2010-10-15
Marketing category
ANDA
Application number
ANDA091269
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE]; Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
LANSOPRAZOLE30 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii0K5C5T2QPG
Rxcui311277
Spl Set Id12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd
Manufacturer NameA-S Medication Solutions

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0K5C5T2QPGLANSOPRAZOLE103577-45-3LANSOPRAZOLE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6830-05009068300090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6830-0) 2023-11-21NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LansoprazoleA-S Medication Solutions2023-11-28HUMAN PRESCRIPTION DRUG LABEL16