naproxen and esomeprazole magnesium

Generic: naproxen and esomeprazole magnesium

Labeler: dr. reddy's laboratories limited
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 dr. reddy's laboratories limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-289
Product ID 55111-289_e222148e-ce6f-2205-e8e3-4e40219a12f1
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 55111289
Hyphenated Format 55111-289

Supplemental Identifiers

RxCUI
994005 994008
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 ANDA204206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 375 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60)
source: ndc

Packages (1)

55111-289-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60)

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": "e222148e-ce6f-2205-e8e3-4e40219a12f1", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ", "R6DXU4WAY9"], "rxcui": ["994005", "994008"], "spl_set_id": ["1ef3fe94-9bbb-934d-a09b-d19a1d23a4d5"], "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": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60)", "package_ndc": "55111-289-60", "marketing_start_date": "20200218"}], "brand_name": "Naproxen and esomeprazole magnesium", "product_id": "55111-289_e222148e-ce6f-2205-e8e3-4e40219a12f1", "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": "55111-289", "generic_name": "Naproxen and esomeprazole magnesium", "labeler_name": "Dr. Reddy's Laboratories Limited", "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": "ANDA204206", "marketing_category": "ANDA", "marketing_start_date": "20200218", "listing_expiration_date": "20261231"}