NDC 68788-6389

Lansoprazole

Lansoprazole

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

Product ID68788-6389_cca963ac-f12f-4544-98c5-df674146d2db
NDC68788-6389
Product TypeHuman Prescription Drug
Proprietary NameLansoprazole
Generic NameLansoprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-05-20
Marketing CategoryANDA / ANDA
Application NumberANDA090331
Labeler NamePreferred 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 68788-6389-4

14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6389-4)
Marketing Start Date2016-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6389-8 [68788638908]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-20
Marketing End Date2019-10-14

NDC 68788-6389-7 [68788638907]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-21
Marketing End Date2019-10-14

NDC 68788-6389-4 [68788638904]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-20
Marketing End Date2019-10-14

NDC 68788-6389-3 [68788638903]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-20
Marketing End Date2019-10-14

NDC 68788-6389-2 [68788638902]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-20
Marketing End Date2019-10-14

NDC 68788-6389-1 [68788638901]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-20
Marketing End Date2019-10-14

NDC 68788-6389-6 [68788638906]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-20
Marketing End Date2019-10-14

NDC 68788-6389-9 [68788638909]

Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-20
Marketing End Date2019-10-14

Drug Details

Active Ingredients

IngredientStrength
LANSOPRAZOLE15 mg/1

OpenFDA Data

SPL SET ID:35a161e8-3e2b-4c98-83f8-b7ddef7ef7de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596843

    • 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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