Home NDC 42254-227
Lansoprazole
Product NDC 42254-227
11-digit product format 422540227
Labeler code 42254
Product ID 42254-227_a9465919-2a5f-40f9-a8e4-ce75f7a651d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lansoprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA077255
Marketing category ANDA
Marketing start 2009-11-11
Marketing end 0000-00-00
Substance LANSOPRAZOLE
Active strength 30 mg/1
Pharmacologic classes Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42254-227-30 Lansoprazole 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 1 42254-227-60 Lansoprazole 60 in 1 BOTTLE CAPSULE, DELAYED RELEASE 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LANSOPRAZOLE ACTIVE INGREDIENT 0K5C5T2QPG LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 LANSOPRAZOLE ACTIVE MOIETY 0K5C5T2QPG LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM CARBONATE INACTIVE INGREDIENT 0E53J927NA LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42254-227 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 2 package rows 20130228_a9465919-2a5f-40f9-a8e4-ce75f7a651d4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42254-227-30 42254022730 30 in 1 BOTTLE Historical 42254-227-60 42254022760 60 in 1 BOTTLE Historical