esomeprazole magnesium

Generic: esomeprazole magnesium delayed release capsules

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium delayed release capsules
Labeler ascend laboratories, llc
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-571
Product ID 67877-571_27b22eed-c148-41cd-bdd7-434610f98b70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210559
Listing Expiration 2026-12-31
Marketing Start 2021-02-27

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 67877571
Hyphenated Format 67877-571

Supplemental Identifiers

RxCUI
606726 606730
UPC
0367877571300
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 delayed release capsules (source: ndc)
Application Number ANDA210559 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05)
  • 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-10)
  • 30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-30)
  • 10 BLISTER PACK in 1 CARTON (67877-571-38) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
  • 90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-90)
source: ndc

Packages (5)

67877-571-05 500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05) 67877-571-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-10) 67877-571-30 30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-30) 67877-571-38 10 BLISTER PACK in 1 CARTON (67877-571-38) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK 67877-571-90 90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-90)

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": "27b22eed-c148-41cd-bdd7-434610f98b70", "openfda": {"upc": ["0367877571300"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["277ce748-2809-4be0-81e7-6a4d604f2c6f"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05)", "package_ndc": "67877-571-05", "marketing_start_date": "20210227"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-10)", "package_ndc": "67877-571-10", "marketing_start_date": "20210227"}, {"sample": false, "description": "30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-30)", "package_ndc": "67877-571-30", "marketing_start_date": "20210227"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-571-38)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK", "package_ndc": "67877-571-38", "marketing_start_date": "20210227"}, {"sample": false, "description": "90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-90)", "package_ndc": "67877-571-90", "marketing_start_date": "20210227"}], "brand_name": "Esomeprazole magnesium", "product_id": "67877-571_27b22eed-c148-41cd-bdd7-434610f98b70", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "67877-571", "generic_name": "Esomeprazole magnesium delayed release capsules", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA210559", "marketing_category": "ANDA", "marketing_start_date": "20210227", "listing_expiration_date": "20261231"}