esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium 20 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-880
Product ID 16571-880_cd6b21e6-4d3f-40b5-89ee-52a1c83d8700
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216349
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

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 16571880
Hyphenated Format 16571-880

Supplemental Identifiers

RxCUI
606726
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 ANDA216349 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (16571-880-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (16571-880-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

16571-880-41 1 BOTTLE in 1 CARTON (16571-880-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 16571-880-42 3 BOTTLE in 1 CARTON (16571-880-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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": "cd6b21e6-4d3f-40b5-89ee-52a1c83d8700", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["07ba5747-702f-47fc-9d80-5a70296b64bf"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (16571-880-41)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "16571-880-41", "marketing_start_date": "20221201"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (16571-880-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "16571-880-42", "marketing_start_date": "20221201"}], "brand_name": "ESOMEPRAZOLE MAGNESIUM", "product_id": "16571-880_cd6b21e6-4d3f-40b5-89ee-52a1c83d8700", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "16571-880", "generic_name": "ESOMEPRAZOLE MAGNESIUM", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ESOMEPRAZOLE MAGNESIUM", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA216349", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}