naprelan

Generic: naproxen sodium

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name naprelan
Generic Name naproxen sodium
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 500 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-250
Product ID 24979-250_1ae3fb8f-0340-45e5-9f71-fe284c0a6037
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020353
Listing Expiration 2027-12-31
Marketing Start 2025-12-31

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 24979250
Hyphenated Format 24979-250

Supplemental Identifiers

RxCUI
1116320 1116331 1116339 1116341 1116349 1116351
UPC
0324979249018 0324979251066 0324979250687
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
  • 500 mg/1
source: ndc
Packaging
  • 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-250-68)
source: ndc

Packages (1)

24979-250-68 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-250-68)

Ingredients (1)

naproxen sodium (500 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": "1ae3fb8f-0340-45e5-9f71-fe284c0a6037", "openfda": {"upc": ["0324979249018", "0324979251066", "0324979250687"], "unii": ["9TN87S3A3C"], "rxcui": ["1116320", "1116331", "1116339", "1116341", "1116349", "1116351"], "spl_set_id": ["b8a51c9a-488e-4377-a041-436f6a2f8893"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-250-68)", "package_ndc": "24979-250-68", "marketing_start_date": "20251231"}], "brand_name": "Naprelan", "product_id": "24979-250_1ae3fb8f-0340-45e5-9f71-fe284c0a6037", "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": "24979-250", "generic_name": "Naproxen Sodium", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naprelan", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "500 mg/1"}], "application_number": "NDA020353", "marketing_category": "NDA", "marketing_start_date": "20251231", "listing_expiration_date": "20271231"}