omeprazole/sodium bicarbonate

Generic: omeprazole

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole/sodium bicarbonate
Generic Name omeprazole
Labeler strides pharma science limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1700mg, sodium bicarbonate 1680 mg/1700mg

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-182
Product ID 64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079182
Listing Expiration 2026-12-31
Marketing Start 2022-10-01

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 64380182
Hyphenated Format 64380-182

Supplemental Identifiers

RxCUI
753557 753562
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/sodium bicarbonate (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA079182 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1700mg
  • 1680 mg/1700mg
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (64380-182-02) / 20 mg in 1 POUCH (64380-182-01)
source: ndc

Packages (1)

64380-182-02 30 POUCH in 1 CARTON (64380-182-02) / 20 mg in 1 POUCH (64380-182-01)

Ingredients (2)

omeprazole (20 mg/1700mg) sodium bicarbonate (1680 mg/1700mg)

Linked Drug Pages (1)

Omeprazole/Sodium Bicarbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ac68a93-2f3b-46aa-a874-c109ad1bfefe", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["753557", "753562"], "spl_set_id": ["cf6d293e-d70d-443e-8292-d693e93aab55"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (64380-182-02)  / 20 mg in 1 POUCH (64380-182-01)", "package_ndc": "64380-182-02", "marketing_start_date": "20221001"}], "brand_name": "Omeprazole/Sodium Bicarbonate", "product_id": "64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefe", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "64380-182", "generic_name": "omeprazole", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole/Sodium Bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1700mg"}, {"name": "SODIUM BICARBONATE", "strength": "1680 mg/1700mg"}], "application_number": "ANDA079182", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20261231"}