naproxen and esomeprazole magnesium (68788-4043)

Drug Facts

Product Profile

Brand Name naproxen and esomeprazole magnesium

Generic Name naproxen and esomeprazole magnesium

Labeler preferred pharmaceuticals inc.

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

esomeprazole magnesium trihydrate 20 mg/1, naproxen 500 mg/1

Manufacturer

Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-4043

Product ID 68788-4043_6368a3be-4b79-466b-8ec4-11fc3ac623cc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204206

Listing Expiration 2026-12-31

Marketing Start 2025-10-17

Pharmacologic Class

Established (EPC)

nonsteroidal anti-inflammatory drug [epc]

Mechanism of Action

cyclooxygenase inhibitors [moa]

Chemical Structure

anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687884043

Hyphenated Format 68788-4043

Supplemental Identifiers

RxCUI

994008

UNII

R6DXU4WAY9 57Y76R9ATQ

NUI

N0000000160 M0001335 N0000175722

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 naproxen and esomeprazole magnesium (source: ndc)

Generic Name naproxen and esomeprazole magnesium (source: ndc)

Application Number ANDA204206 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
500 mg/1

source: ndc

Packaging

30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-3)
60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-6)

source: ndc

Packages (2)

68788-4043-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-3) 68788-4043-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-6)

Ingredients (2)

esomeprazole magnesium trihydrate (20 mg/1) naproxen (500 mg/1)

Linked Drug Pages (1)

Naproxen and esomeprazole magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "6368a3be-4b79-466b-8ec4-11fc3ac623cc", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["R6DXU4WAY9", "57Y76R9ATQ"], "rxcui": ["994008"], "spl_set_id": ["6368a3be-4b79-466b-8ec4-11fc3ac623cc"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-3)", "package_ndc": "68788-4043-3", "marketing_start_date": "20251017"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-6)", "package_ndc": "68788-4043-6", "marketing_start_date": "20251017"}], "brand_name": "Naproxen and esomeprazole magnesium", "product_id": "68788-4043_6368a3be-4b79-466b-8ec4-11fc3ac623cc", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68788-4043", "generic_name": "Naproxen and esomeprazole magnesium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen and esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "20 mg/1"}, {"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA204206", "marketing_category": "ANDA", "marketing_start_date": "20251017", "listing_expiration_date": "20261231"}