NDC 68382-503

omeprazole and sodium bicarbonate

Omeprazole And Sodium Bicarbonate

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

Product ID68382-503_22fcc248-47fc-4156-93d6-40592ac43828
NDC68382-503
Product TypeHuman Otc Drug
Proprietary Nameomeprazole and sodium bicarbonate
Generic NameOmeprazole And Sodium Bicarbonate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-07-19
Marketing CategoryANDA / ANDA
Application NumberANDA203345
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameOMEPRAZOLE; SODIUM BICARBONATE
Active Ingredient Strength20 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-503-04

3 BOTTLE in 1 CARTON (68382-503-04) > 14 CAPSULE in 1 BOTTLE
Marketing Start Date2018-07-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-503-17 [68382050317]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203345
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-19

NDC 68382-503-67 [68382050367]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203345
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-19

NDC 68382-503-04 [68382050304]

omeprazole and sodium bicarbonate CAPSULE
Marketing CategoryANDA
Application NumberANDA203345
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-19

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:e90c63f2-33bf-4b61-beb2-70f592cd23a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616539
  • 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.