omeprazole and sodium bicarbonate (85509-1031)

Drug Facts

Product Profile

Brand Name omeprazole and sodium bicarbonate

Generic Name omeprazole and sodium bicarbonate

Labeler phoenix rx llc

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

omeprazole 20 mg/1, sodium bicarbonate 1100 mg/1

Manufacturer

PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1031

Product ID 85509-1031_3b2bf542-9d8a-6ff6-e063-6394a90a3fae

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204228

Listing Expiration 2026-12-31

Marketing Start 2016-07-15

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 855091031

Hyphenated Format 85509-1031

Supplemental Identifiers

RxCUI

616539

UNII

KG60484QX9 8MDF5V39QO

NUI

N0000175525 N0000000147 N0000182140

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 and sodium bicarbonate (source: ndc)

Generic Name omeprazole and sodium bicarbonate (source: ndc)

Application Number ANDA204228 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
1100 mg/1

source: ndc

Packaging

15 CAPSULE in 1 BOTTLE (85509-1031-1)
30 CAPSULE in 1 BOTTLE (85509-1031-3)
60 CAPSULE in 1 BOTTLE (85509-1031-6)

source: ndc

Packages (3)

85509-1031-1 15 CAPSULE in 1 BOTTLE (85509-1031-1) 85509-1031-3 30 CAPSULE in 1 BOTTLE (85509-1031-3) 85509-1031-6 60 CAPSULE in 1 BOTTLE (85509-1031-6)

Ingredients (2)

omeprazole (20 mg/1) sodium bicarbonate (1100 mg/1)

Linked Drug Pages (1)

Omeprazole and Sodium Bicarbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3b2bf542-9d8a-6ff6-e063-6394a90a3fae", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["616539"], "spl_set_id": ["3b2bf501-fd81-6ffa-e063-6394a90afe42"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BOTTLE (85509-1031-1)", "package_ndc": "85509-1031-1", "marketing_start_date": "20250730"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (85509-1031-3)", "package_ndc": "85509-1031-3", "marketing_start_date": "20250730"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (85509-1031-6)", "package_ndc": "85509-1031-6", "marketing_start_date": "20250730"}], "brand_name": "Omeprazole and Sodium Bicarbonate", "product_id": "85509-1031_3b2bf542-9d8a-6ff6-e063-6394a90a3fae", "dosage_form": "CAPSULE", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "85509-1031", "generic_name": "Omeprazole and Sodium Bicarbonate", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole and Sodium Bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1100 mg/1"}], "application_number": "ANDA204228", "marketing_category": "ANDA", "marketing_start_date": "20160715", "listing_expiration_date": "20261231"}