NDC 55315-019

Lansoprazole

Lansoprazole

Lansoprazole is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Freds Inc. The primary component is Lansoprazole.

Product ID55315-019_899ee4ee-6eca-4003-bbd2-a946582387c9
NDC55315-019
Product TypeHuman Otc Drug
Proprietary NameLansoprazole
Generic NameLansoprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2012-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA202727
Labeler NameFreds Inc
Substance NameLANSOPRAZOLE
Active Ingredient Strength15 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55315-019-14

1 BLISTER PACK in 1 BOX (55315-019-14) > 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2012-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-019-14 [55315001914]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202727
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LANSOPRAZOLE15 mg/1

OpenFDA Data

SPL SET ID:04b78e0f-f272-45e8-b07f-78de54cb6756
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596843
  • NDC Crossover Matching brand name "Lansoprazole" or generic name "Lansoprazole"

    NDCBrand NameGeneric Name
    0093-3008LansoprazoleLansoprazole
    0093-3009LansoprazoleLansoprazole
    0093-7350LansoprazoleLansoprazole
    0093-7351LansoprazoleLansoprazole
    67877-274LansoprazoleLansoprazole
    67877-275LansoprazoleLansoprazole
    68001-111LansoprazoleLansoprazole
    68001-112LansoprazoleLansoprazole
    68016-132LansoprazoleLansoprazole
    68016-756LansoprazoleLansoprazole
    68071-3019lansoprazolelansoprazole
    68071-1972LansoprazoleLansoprazole
    68071-4456LansoprazoleLansoprazole
    68196-019LansoprazoleLansoprazole
    68196-030LansoprazoleLansoprazole
    68382-543lansoprazolelansoprazole
    68382-544lansoprazolelansoprazole
    68382-771LANSOPRAZOLELANSOPRAZOLE
    68382-772LANSOPRAZOLELANSOPRAZOLE
    68788-6390LansoprazoleLansoprazole
    68788-6389LansoprazoleLansoprazole
    68788-7385lansoprazolelansoprazole
    68788-8915LansoprazoleLansoprazole
    68788-9281LansoprazoleLansoprazole
    68788-9269LansoprazoleLansoprazole
    68788-9406LansoprazoleLansoprazole
    68788-8999LansoprazoleLansoprazole
    68788-9677LansoprazoleLansoprazole
    69336-107LANSOPRAZOLELANSOPRAZOLE
    69842-507LansoprazoleLansoprazole
    0591-2448LansoprazoleLansoprazole
    70756-807LansoprazoleLansoprazole
    70771-1132LANSOPRAZOLELANSOPRAZOLE
    70700-262LansoprazoleLansoprazole
    70771-1133LANSOPRAZOLELANSOPRAZOLE
    70700-263LansoprazoleLansoprazole
    70756-806LansoprazoleLansoprazole
    71335-0058LansoprazoleLansoprazole
    71335-0043LansoprazoleLansoprazole
    71335-0660LansoprazoleLansoprazole
    71335-0105lansoprazolelansoprazole
    71335-0917LansoprazoleLansoprazole
    71335-0575lansoprazolelansoprazole
    0781-2148LansoprazoleLansoprazole
    0781-2147LansoprazoleLansoprazole
    0904-6662LansoprazoleLansoprazole
    11822-0117lansoprazolelansoprazole
    21130-019LansoprazoleLansoprazole
    21695-652LansoprazoleLansoprazole
    21695-474LansoprazoleLansoprazole

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.