naproxen and esomeprazole magnesium

Generic: naproxen and esomeprazole magnesium

Labeler: sciegen pharmaceuticals, 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 sciegen pharmaceuticals, inc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-438
Product ID 50228-438_2faf3061-f567-a5dc-e063-6294a90aff8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217738
Listing Expiration 2026-12-31
Marketing Start 2023-10-11

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 50228438
Hyphenated Format 50228-438

Supplemental Identifiers

RxCUI
994005 994008
UPC
0350228437103 0350228438605 0350228438056 0350228437301 0350228437608 0350228438308
UNII
57Y76R9ATQ R6DXU4WAY9
NUI
N0000000160 M0001335 N0000175722

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 naproxen and esomeprazole magnesium (source: ndc)
Generic Name naproxen and esomeprazole magnesium (source: ndc)
Application Number ANDA217738 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-05)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-60)
source: ndc

Packages (3)

50228-438-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-05) 50228-438-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-30) 50228-438-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-60)

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": "2faf3061-f567-a5dc-e063-6294a90aff8b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0350228437103", "0350228438605", "0350228438056", "0350228437301", "0350228437608", "0350228438308"], "unii": ["57Y76R9ATQ", "R6DXU4WAY9"], "rxcui": ["994005", "994008"], "spl_set_id": ["167340c2-1234-4d00-b4e2-cccf3d270fda"], "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": ["ScieGen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-05)", "package_ndc": "50228-438-05", "marketing_start_date": "20231011"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-30)", "package_ndc": "50228-438-30", "marketing_start_date": "20231011"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-60)", "package_ndc": "50228-438-60", "marketing_start_date": "20240312"}], "brand_name": "Naproxen and esomeprazole magnesium", "product_id": "50228-438_2faf3061-f567-a5dc-e063-6294a90aff8b", "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": "50228-438", "generic_name": "Naproxen and esomeprazole magnesium", "labeler_name": "ScieGen Pharmaceuticals, 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": "ANDA217738", "marketing_category": "ANDA", "marketing_start_date": "20231011", "listing_expiration_date": "20261231"}