NDC 42291-585

Omeprazole/Bicarbonate

Omeprazole And Sodium Bicarbonate

Omeprazole/Bicarbonate is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Omeprazole; Sodium Bicarbonate.

Product ID42291-585_84241488-f18d-6bb5-e053-2991aa0a2f78
NDC42291-585
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole/Bicarbonate
Generic NameOmeprazole And Sodium Bicarbonate
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2019-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA207476
Labeler NameAvKARE, Inc.
Substance NameOMEPRAZOLE; SODIUM BICARBONATE
Active Ingredient Strength40 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 42291-585-30

30 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-585-30)
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-585-30 [42291058530]

Omeprazole/Bicarbonate CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA207476
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE40 mg/1

OpenFDA Data

SPL SET ID:8424052c-bd78-a95f-e053-2a91aa0aa2de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616541
  • UPC Code
  • 0342291585300
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Omeprazole/Bicarbonate" or generic name "Omeprazole And Sodium Bicarbonate"

    NDCBrand NameGeneric Name
    42291-585Omeprazole/BicarbonateOmeprazole and Sodium Bicarbonate
    69367-196Omeprazole/BicarbonateOmeprazole/Bicarbonate
    69367-195Omeprazole/BicarbonateOmeprazole/Bicarbonate
    71205-985Omeprazole/BicarbonateOmeprazole/Bicarbonate
    71205-984Omeprazole/BicarbonateOmeprazole/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
    50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    49884-268Omeprazole/Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    49884-269Omeprazole/Sodium BicarbonateOmeprazole and Sodium Bicarbonate
    11523-7265Zegerid OTCOmeprazole and Sodium Bicarbonate
    11523-7276Zegerid OTComeprazole and sodium bicarbonate

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