esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: biocon pharma inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler biocon pharma inc.,
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Biocon Pharma Inc.,

Identifiers & Regulatory

Product NDC 70377-055
Product ID 70377-055_b4ff12a6-841e-4eff-b9a4-bb814230eea5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213486
Listing Expiration 2026-12-31
Marketing Start 2021-03-19

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 70377055
Hyphenated Format 70377-055

Supplemental Identifiers

RxCUI
606726 606730
UPC
0370377055119
UNII
R6DXU4WAY9

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 ANDA213486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-11)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-12)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-13)
source: ndc

Packages (3)

70377-055-11 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-11) 70377-055-12 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-12) 70377-055-13 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-13)

Ingredients (1)

esomeprazole magnesium (20 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": "b4ff12a6-841e-4eff-b9a4-bb814230eea5", "openfda": {"upc": ["0370377055119"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9"], "manufacturer_name": ["Biocon Pharma Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-11)", "package_ndc": "70377-055-11", "marketing_start_date": "20210319"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-12)", "package_ndc": "70377-055-12", "marketing_start_date": "20210319"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-13)", "package_ndc": "70377-055-13", "marketing_start_date": "20210319"}], "brand_name": "esomeprazole magnesium", "product_id": "70377-055_b4ff12a6-841e-4eff-b9a4-bb814230eea5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70377-055", "generic_name": "esomeprazole magnesium", "labeler_name": "Biocon Pharma Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA213486", "marketing_category": "ANDA", "marketing_start_date": "20210319", "listing_expiration_date": "20261231"}