esomeprazole

Generic: esomeprazole

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole
Generic Name esomeprazole
Labeler macleods pharmaceuticals limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole 20 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-306
Product ID 33342-306_d68c9247-91c7-4e0f-adc4-2cfa7446580f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208511
Listing Expiration 2026-12-31
Marketing Start 2024-10-23

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 33342306
Hyphenated Format 33342-306

Supplemental Identifiers

RxCUI
606726 606730
UPC
0333342307101 0333342307071
UNII
N3PA6559FT
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 esomeprazole (source: ndc)
Generic Name esomeprazole (source: ndc)
Application Number ANDA208511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-07)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-10)
source: ndc

Packages (2)

33342-306-07 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-07) 33342-306-10 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-10)

Ingredients (1)

esomeprazole (20 mg/1)

Linked Drug Pages (1)

esomeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d68c9247-91c7-4e0f-adc4-2cfa7446580f", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0333342307101", "0333342307071"], "unii": ["N3PA6559FT"], "rxcui": ["606726", "606730"], "spl_set_id": ["d68c9247-91c7-4e0f-adc4-2cfa7446580f"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-07)", "package_ndc": "33342-306-07", "marketing_start_date": "20241023"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-10)", "package_ndc": "33342-306-10", "marketing_start_date": "20241023"}], "brand_name": "esomeprazole", "product_id": "33342-306_d68c9247-91c7-4e0f-adc4-2cfa7446580f", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "33342-306", "generic_name": "esomeprazole", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esomeprazole", "active_ingredients": [{"name": "ESOMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA208511", "marketing_category": "ANDA", "marketing_start_date": "20241023", "listing_expiration_date": "20261231"}