naproxen and esomeprazole magnesium (85509-1202)

Drug Facts

Product Profile

Brand Name naproxen and esomeprazole magnesium

Generic Name naproxen and esomeprazole magnesium

Labeler phoenix rx llc

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

esomeprazole magnesium 20 mg/1, naproxen 375 mg/1

Manufacturer

PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1202

Product ID 85509-1202_3a663855-6d4e-71ee-e063-6394a90adb5d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213699

Listing Expiration 2026-12-31

Marketing Start 2022-10-06

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 855091202

Hyphenated Format 85509-1202

Supplemental Identifiers

RxCUI

994005

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 ANDA213699 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
375 mg/1

source: ndc

Packaging

30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-3)
60 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-6)

source: ndc

Packages (2)

85509-1202-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-3) 85509-1202-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-6)

Ingredients (2)

esomeprazole magnesium (20 mg/1) naproxen (375 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": "3a663855-6d4e-71ee-e063-6394a90adb5d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["R6DXU4WAY9", "57Y76R9ATQ"], "rxcui": ["994005"], "spl_set_id": ["3a6637ca-0c55-f648-e063-6294a90aaef7"], "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": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-3)", "package_ndc": "85509-1202-3", "marketing_start_date": "20250721"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-6)", "package_ndc": "85509-1202-6", "marketing_start_date": "20250721"}], "brand_name": "Naproxen and esomeprazole magnesium", "product_id": "85509-1202_3a663855-6d4e-71ee-e063-6394a90adb5d", "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": "85509-1202", "generic_name": "Naproxen and esomeprazole magnesium", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen and esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}, {"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA213699", "marketing_category": "ANDA", "marketing_start_date": "20221006", "listing_expiration_date": "20261231"}