esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler zydus pharmaceuticals usa inc.
Dosage Form GRANULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium dihydrate 40 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-849
Product ID 68382-849_bc31956a-671b-4ca3-b9dd-1fdb03003cae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206055
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

Pharmacologic Class

Classes
cytochrome p450 2c19 inhibitors [moa] proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382849
Hyphenated Format 68382-849

Supplemental Identifiers

RxCUI
692576 692578
UNII
36H71644EQ

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 magnesium (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA206055 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-849-94)
source: ndc

Packages (1)

68382-849-94 30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-849-94)

Ingredients (1)

esomeprazole magnesium dihydrate (40 mg/1)

Linked Drug Pages (1)

Esomeprazole Magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bc31956a-671b-4ca3-b9dd-1fdb03003cae", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["692576", "692578"], "spl_set_id": ["190a4c5b-1547-45d7-b00b-10da4131e2e2"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-849-94)", "package_ndc": "68382-849-94", "marketing_start_date": "20230630"}], "brand_name": "Esomeprazole Magnesium", "product_id": "68382-849_bc31956a-671b-4ca3-b9dd-1fdb03003cae", "dosage_form": "GRANULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68382-849", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA206055", "marketing_category": "ANDA", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}