omeprazole and sodium bicarbonate

Generic: omeprazole and sodium bicarbonate

Labeler: dr. reddy's laboratories inc.,
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole and sodium bicarbonate
Generic Name omeprazole and sodium bicarbonate
Labeler dr. reddy's laboratories inc.,
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1, sodium bicarbonate 1680 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-307
Product ID 43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217784
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

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 43598307
Hyphenated Format 43598-307

Supplemental Identifiers

RxCUI
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 and sodium bicarbonate (source: ndc)
Generic Name omeprazole and sodium bicarbonate (source: ndc)
Application Number ANDA217784 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 1680 mg/1
source: ndc
Packaging
  • 1 PACKET in 1 CARTON (43598-307-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET
  • 14 PACKET in 1 CARTON (43598-307-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET
  • 28 PACKET in 1 CARTON (43598-307-28) / 1 POWDER, FOR SUSPENSION in 1 PACKET
  • 42 PACKET in 1 CARTON (43598-307-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET
source: ndc

Packages (4)

43598-307-01 1 PACKET in 1 CARTON (43598-307-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET 43598-307-14 14 PACKET in 1 CARTON (43598-307-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET 43598-307-28 28 PACKET in 1 CARTON (43598-307-28) / 1 POWDER, FOR SUSPENSION in 1 PACKET 43598-307-42 42 PACKET in 1 CARTON (43598-307-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET

Ingredients (2)

omeprazole (20 mg/1) sodium bicarbonate (1680 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": "dc9f1708-68a6-cb89-36c5-4e5fdb30100e", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["753562"], "spl_set_id": ["c6b5f808-4a49-1303-9711-badb022ecd70"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 PACKET in 1 CARTON (43598-307-01)  / 1 POWDER, FOR SUSPENSION in 1 PACKET", "package_ndc": "43598-307-01", "marketing_start_date": "20240715"}, {"sample": false, "description": "14 PACKET in 1 CARTON (43598-307-14)  / 1 POWDER, FOR SUSPENSION in 1 PACKET", "package_ndc": "43598-307-14", "marketing_start_date": "20240715"}, {"sample": false, "description": "28 PACKET in 1 CARTON (43598-307-28)  / 1 POWDER, FOR SUSPENSION in 1 PACKET", "package_ndc": "43598-307-28", "marketing_start_date": "20240715"}, {"sample": false, "description": "42 PACKET in 1 CARTON (43598-307-42)  / 1 POWDER, FOR SUSPENSION in 1 PACKET", "package_ndc": "43598-307-42", "marketing_start_date": "20240715"}], "brand_name": "Omeprazole and Sodium Bicarbonate", "product_id": "43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100e", "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": "43598-307", "generic_name": "Omeprazole and Sodium Bicarbonate", "labeler_name": "Dr. Reddy's Laboratories Inc.,", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole and Sodium Bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1680 mg/1"}], "application_number": "ANDA217784", "marketing_category": "ANDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}