NDC 0378-8015

Lansoprazole

Lansoprazole

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

Product ID0378-8015_1a3a51b2-a5a2-43d3-bc53-1c3f23e9ea1d
NDC0378-8015
Product TypeHuman Prescription Drug
Proprietary NameLansoprazole
Generic NameLansoprazole
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2009-11-10
Marketing CategoryANDA / ANDA
Application NumberANDA090763
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 Through2019-12-31

Packaging

NDC 0378-8015-93

30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-93)
Marketing Start Date2009-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8015-10 [00378801510]

Lansoprazole CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-10
Marketing End Date2018-03-31

NDC 0378-8015-93 [00378801593]

Lansoprazole CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-10

NDC 0378-8015-01 [00378801501]

Lansoprazole CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-10
Marketing End Date2015-01-29

Drug Details

Active Ingredients

IngredientStrength
LANSOPRAZOLE15 mg/1

OpenFDA Data

SPL SET ID:c8fa7401-907f-41b6-a2e1-f4bc214f2cdf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311277
  • 596843
  • UPC Code
  • 0303788015939
  • Pharmacological Class

    • 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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