NDC 0378-6981

Lansoprazole

Lansoprazole

Lansoprazole is a Oral Tablet, Orally Disintegrating, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Lansoprazole.

Product ID0378-6981_20ff347c-ca18-497b-948d-1145035f2ffc
NDC0378-6981
Product TypeHuman Prescription Drug
Proprietary NameLansoprazole
Generic NameLansoprazole
Dosage FormTablet, Orally Disintegrating, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA202396
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLANSOPRAZOLE
Active Ingredient Strength15 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-6981-88

2 CARTON in 1 BOX (0378-6981-88) > 5 BLISTER PACK in 1 CARTON (0378-6981-85) > 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0378-6981-32)
Marketing Start Date2018-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6981-85 [00378698185]

Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202396
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-29

NDC 0378-6981-88 [00378698188]

Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202396
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-29

NDC 0378-6981-32 [00378698132]

Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202396
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-29

Drug Details

Active Ingredients

IngredientStrength
LANSOPRAZOLE15 mg/1

OpenFDA Data

SPL SET ID:20ff347c-ca18-497b-948d-1145035f2ffc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351261
  • 351260
  • UPC Code
  • 0303786982936
  • 0303786981939
  • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Inhibition Gastric Acid Secretion [PE]
    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Inhibition Gastric Acid Secretion [PE]

    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

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