Home NDC 42254-331 Lansoprazole
Product NDC 42254-331
11-digit product format 422540331
Labeler code 42254
Product ID 42254-331_152fb727-d516-441e-a72b-33ddf1a325c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lansoprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA091269
Marketing category ANDA
Marketing start 2010-10-15
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 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 42254-331-30 Lansoprazole 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 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 ammonia INACTIVE INGREDIENT 5138Q19F1X LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 gelatin INACTIVE INGREDIENT 2G86QN327L LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P 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 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 raw sugar INACTIVE INGREDIENT 8M707QY5GH LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 shellac INACTIVE INGREDIENT 46N107B71O LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J 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
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42254-331 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 1 package rows 20130228_152fb727-d516-441e-a72b-33ddf1a325c1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42254-331-30 42254033130 30 in 1 BOTTLE Historical