naprelan

Generic: naproxen sodium

Labeler: almatica pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name naprelan
Generic Name naproxen sodium
Labeler almatica pharma llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 750 mg/1

Manufacturer
Almatica Pharma LLC

Identifiers & Regulatory

Product NDC 52427-274
Product ID 52427-274_cc98185d-7e2e-eea6-8bbd-08585361b654
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020353
Marketing Start 2014-01-17
Marketing End 2026-04-01

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52427274
Hyphenated Format 52427-274

Supplemental Identifiers

RxCUI
1116320 1116331 1116339 1116341 1116349 1116351
UPC
0352427272011 0352427274305 0352427273759
UNII
9TN87S3A3C

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 naprelan (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number NDA020353 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-274-30)
source: ndc

Packages (1)

52427-274-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-274-30)

Ingredients (1)

naproxen sodium (750 mg/1)

Linked Drug Pages (1)

Naprelan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cc98185d-7e2e-eea6-8bbd-08585361b654", "openfda": {"upc": ["0352427272011", "0352427274305", "0352427273759"], "unii": ["9TN87S3A3C"], "rxcui": ["1116320", "1116331", "1116339", "1116341", "1116349", "1116351"], "spl_set_id": ["e633ff0b-eab7-f167-8d08-e9236e54042b"], "manufacturer_name": ["Almatica Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-274-30)", "package_ndc": "52427-274-30", "marketing_end_date": "20260401", "marketing_start_date": "20140117"}], "brand_name": "Naprelan", "product_id": "52427-274_cc98185d-7e2e-eea6-8bbd-08585361b654", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "52427-274", "generic_name": "Naproxen Sodium", "labeler_name": "Almatica Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naprelan", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "750 mg/1"}], "application_number": "NDA020353", "marketing_category": "NDA", "marketing_end_date": "20260401", "marketing_start_date": "20140117"}