naproxen and esomeprazole magnesium

Generic: naproxen and esomeprazole magnesium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen and esomeprazole magnesium
Generic Name naproxen and esomeprazole magnesium
Labeler asclemed usa, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-889
Product ID 76420-889_2a4fb535-ba1a-05d6-e063-6394a90a0b29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204206
Listing Expiration 2026-12-31
Marketing Start 2020-02-18

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 76420889
Hyphenated Format 76420-889

Supplemental Identifiers

RxCUI
994005 994008
UNII
57Y76R9ATQ R6DXU4WAY9
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
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-01)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-60)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-90)
source: ndc

Packages (4)

76420-889-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-01) 76420-889-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-30) 76420-889-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-60) 76420-889-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-90)

Ingredients (2)

esomeprazole magnesium (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": "2a4fb535-ba1a-05d6-e063-6394a90a0b29", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ", "R6DXU4WAY9"], "rxcui": ["994005", "994008"], "spl_set_id": ["7b3af5a8-0c92-43f4-af13-7a47dca20e92"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-01)", "package_ndc": "76420-889-01", "marketing_start_date": "20241228"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-30)", "package_ndc": "76420-889-30", "marketing_start_date": "20241228"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-60)", "package_ndc": "76420-889-60", "marketing_start_date": "20241228"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-90)", "package_ndc": "76420-889-90", "marketing_start_date": "20241228"}], "brand_name": "Naproxen and esomeprazole magnesium", "product_id": "76420-889_2a4fb535-ba1a-05d6-e063-6394a90a0b29", "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": "76420-889", "generic_name": "Naproxen and esomeprazole magnesium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen and esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}, {"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA204206", "marketing_category": "ANDA", "marketing_start_date": "20200218", "listing_expiration_date": "20261231"}