naproxen and esomeprazole magnesium (27241-203)

Drug Facts

Product Profile

Brand Name naproxen and esomeprazole magnesium

Generic Name naproxen and esomeprazole magnesium

Labeler ajanta pharma usa inc.

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-203

Product ID 27241-203_da976bfa-7910-489a-bfc1-3944dfc597e4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213699

Listing Expiration 2027-12-31

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 27241203

Hyphenated Format 27241-203

Supplemental Identifiers

RxCUI

994005 994008

UPC

0327241203602 0327241202605

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 ANDA213699 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
500 mg/1

source: ndc

Packaging

60 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-203-60)

source: ndc

Packages (1)

27241-203-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-203-60)

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": "da976bfa-7910-489a-bfc1-3944dfc597e4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0327241203602", "0327241202605"], "unii": ["57Y76R9ATQ", "R6DXU4WAY9"], "rxcui": ["994005", "994008"], "spl_set_id": ["7ca657dc-4376-4693-8568-99351fac8186"], "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": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-203-60)", "package_ndc": "27241-203-60", "marketing_start_date": "20221006"}], "brand_name": "Naproxen and esomeprazole magnesium", "product_id": "27241-203_da976bfa-7910-489a-bfc1-3944dfc597e4", "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": "27241-203", "generic_name": "Naproxen and esomeprazole magnesium", "labeler_name": "Ajanta Pharma 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": "ANDA213699", "marketing_category": "ANDA", "marketing_start_date": "20221006", "listing_expiration_date": "20271231"}