NDC 68382-501

omeprazole and sodium bicarbonate

Omeprazole And Sodium Bicarbonate

omeprazole and sodium bicarbonate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Omeprazole; Sodium Bicarbonate.

Product ID68382-501_1eb7105a-d486-4ffd-b000-c4b0bcb7dafa
NDC68382-501
Product TypeHuman Prescription Drug
Proprietary Nameomeprazole and sodium bicarbonate
Generic NameOmeprazole And Sodium Bicarbonate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-05-29
Marketing CategoryANDA / ANDA
Application NumberANDA203290
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameOMEPRAZOLE; SODIUM BICARBONATE
Active Ingredient Strength20 mg/1; mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-501-01

100 CAPSULE in 1 BOTTLE (68382-501-01)
Marketing Start Date2018-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-501-10 [68382050110]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-29

NDC 68382-501-30 [68382050130]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-29

NDC 68382-501-67 [68382050167]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-29

NDC 68382-501-77 [68382050177]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-29

NDC 68382-501-01 [68382050101]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-29

NDC 68382-501-05 [68382050105]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-29

NDC 68382-501-06 [68382050106]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-29

NDC 68382-501-16 [68382050116]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-29

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:47d7ca30-d1ee-475a-b59a-3045f97dafe0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616541
  • 616539
  • UPC Code
  • 0368382501066
  • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    Medicade Reported Pricing

    68382050106 OMEPRAZOLE-BICARB 20-1,100 CAP

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "omeprazole and sodium bicarbonate" or generic name "Omeprazole And Sodium Bicarbonate"

    NDCBrand NameGeneric Name
    0363-0732Omeprazole and sodium bicarbonateOmeprazole, sodium bicarbonate
    13107-115Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    13107-116Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    13107-117Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    16714-508Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    16714-509Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    27241-029Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    27241-030Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    37808-732Omeprazole and sodium bicarbonateOmeprazole, sodium bicarbonate
    41250-938omeprazole and sodium bicarbonateOmeprazole, sodium bicarbonate
    68382-501omeprazole and sodium bicarbonateomeprazole and sodium bicarbonate
    68382-502omeprazole and sodium bicarbonateomeprazole and sodium bicarbonate
    68382-503omeprazole and sodium bicarbonateomeprazole and sodium bicarbonate
    68682-990Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    68682-991Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    68682-102Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    68682-104Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    69665-216Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    70771-1101omeprazole and sodium bicarbonateomeprazole and sodium bicarbonate
    70771-1102omeprazole and sodium bicarbonateomeprazole and sodium bicarbonate
    70771-1337omeprazole and sodium bicarbonateomeprazole and sodium bicarbonate
    50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    50228-364Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    59779-732Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    42291-585Omeprazole/BicarbonateOmeprazole and Sodium Bicarbonate
    49884-268Omeprazole/Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    11523-7265Zegerid OTCOmeprazole and Sodium Bicarbonate
    11523-7276Zegerid OTComeprazole and sodium bicarbonate

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