esomeprazole magnesium

Generic: esomeprazole magnesium

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

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler ascend laboratories, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-478
Product ID 67877-478_c6b5c112-5f5b-453a-836f-54bac8c7dca9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208333
Listing Expiration 2026-12-31
Marketing Start 2017-10-20

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 67877478
Hyphenated Format 67877-478

Supplemental Identifiers

RxCUI
606726 606730
UPC
0367877478104
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 ANDA208333 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-05)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-10)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-30)
  • 10 BLISTER PACK in 1 CARTON (67877-478-38) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-90)
source: ndc

Packages (5)

67877-478-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-05) 67877-478-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-10) 67877-478-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-30) 67877-478-38 10 BLISTER PACK in 1 CARTON (67877-478-38) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 67877-478-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-90)

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": "c6b5c112-5f5b-453a-836f-54bac8c7dca9", "openfda": {"upc": ["0367877478104"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["f3d4a0d7-77fd-496e-8dfa-2b2dbace4bac"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-05)", "package_ndc": "67877-478-05", "marketing_start_date": "20171020"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-10)", "package_ndc": "67877-478-10", "marketing_start_date": "20171020"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-30)", "package_ndc": "67877-478-30", "marketing_start_date": "20171020"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-478-38)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "67877-478-38", "marketing_start_date": "20171020"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-90)", "package_ndc": "67877-478-90", "marketing_start_date": "20171020"}], "brand_name": "Esomeprazole magnesium", "product_id": "67877-478_c6b5c112-5f5b-453a-836f-54bac8c7dca9", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "67877-478", "generic_name": "Esomeprazole magnesium", "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": "ANDA208333", "marketing_category": "ANDA", "marketing_start_date": "20171020", "listing_expiration_date": "20261231"}