omeprazole/bicarbonate

Generic: omeprazole and sodium bicarbonate

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole/bicarbonate
Generic Name omeprazole and sodium bicarbonate
Labeler westminster pharmaceuticals, llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1, sodium bicarbonate 1100 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-196
Product ID 69367-196_e19eca95-5e28-47aa-8b41-8f0ca72d170e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207476
Listing Expiration 2027-12-31
Marketing Start 2018-07-27

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367196
Hyphenated Format 69367-196

Supplemental Identifiers

RxCUI
616539 616541
UNII
KG60484QX9 8MDF5V39QO
NUI
N0000175525 N0000000147 N0000182140

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omeprazole/bicarbonate (source: ndc)
Generic Name omeprazole and sodium bicarbonate (source: ndc)
Application Number ANDA207476 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
  • 1100 mg/1
source: ndc
Packaging
  • 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (69367-196-30)
source: ndc

Packages (1)

69367-196-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (69367-196-30)

Ingredients (2)

omeprazole (40 mg/1) sodium bicarbonate (1100 mg/1)

Linked Drug Pages (1)

Omeprazole/Bicarbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e19eca95-5e28-47aa-8b41-8f0ca72d170e", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["616539", "616541"], "spl_set_id": ["d69c2f0f-4e8b-422a-8aaf-a825998b04e0"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (69367-196-30)", "package_ndc": "69367-196-30", "marketing_start_date": "20180727"}], "brand_name": "Omeprazole/Bicarbonate", "product_id": "69367-196_e19eca95-5e28-47aa-8b41-8f0ca72d170e", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69367-196", "generic_name": "Omeprazole and Sodium Bicarbonate", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole/Bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1100 mg/1"}], "application_number": "ANDA207476", "marketing_category": "ANDA", "marketing_start_date": "20180727", "listing_expiration_date": "20271231"}