omeprazole and sodium bicarbonate

Generic: omeprazole and sodium bicarbonate

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole and sodium bicarbonate
Generic Name omeprazole and sodium bicarbonate
Labeler ajanta pharma usa inc.
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

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

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-029
Product ID 27241-029_e627be01-7cc1-4a03-a183-1a5cfe92f9f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205545
Listing Expiration 2027-12-31
Marketing Start 2016-07-27

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 27241029
Hyphenated Format 27241-029

Supplemental Identifiers

RxCUI
753557 753562
UPC
0327241030314
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 ANDA205545 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 1680 mg/1
source: ndc
Packaging
  • 30 FOR SUSPENSION in 1 CARTON (27241-029-31)
  • 1 FOR SUSPENSION in 1 PACKET (27241-029-62)
source: ndc

Packages (2)

27241-029-31 30 FOR SUSPENSION in 1 CARTON (27241-029-31) 27241-029-62 1 FOR SUSPENSION in 1 PACKET (27241-029-62)

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": "e627be01-7cc1-4a03-a183-1a5cfe92f9f0", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0327241030314"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["753557", "753562"], "spl_set_id": ["bd84ca00-6352-4cb3-bce2-05f4a5005a94"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 FOR SUSPENSION in 1 CARTON (27241-029-31)", "package_ndc": "27241-029-31", "marketing_start_date": "20160727"}, {"sample": false, "description": "1 FOR SUSPENSION in 1 PACKET (27241-029-62)", "package_ndc": "27241-029-62", "marketing_start_date": "20160727"}], "brand_name": "Omeprazole and Sodium Bicarbonate", "product_id": "27241-029_e627be01-7cc1-4a03-a183-1a5cfe92f9f0", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "27241-029", "generic_name": "Omeprazole and Sodium Bicarbonate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION 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": "ANDA205545", "marketing_category": "ANDA", "marketing_start_date": "20160727", "listing_expiration_date": "20271231"}