aleve

Generic: naproxen sodium

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aleve
Generic Name naproxen sodium
Labeler bayer healthcare llc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-6080
Product ID 0280-6080_4526c253-b571-1d84-e063-6394a90ae3f9
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021920
Listing Expiration 2026-12-31
Marketing Start 2007-02-20

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 02806080
Hyphenated Format 0280-6080

Supplemental Identifiers

RxCUI
1112231 1112233
UPC
0325866528124
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 aleve (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number NDA021920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 2 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-04) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16)
  • 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
source: ndc

Packages (7)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4526c253-b571-1d84-e063-6394a90ae3f9", "openfda": {"upc": ["0325866528124"], "unii": ["9TN87S3A3C"], "rxcui": ["1112231", "1112233"], "spl_set_id": ["1266393e-b55e-4e34-9710-0b87209f4158"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0280-6080-01)  / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "0280-6080-01", "marketing_start_date": "20070220"}, {"sample": false, "description": "2 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "0280-6080-02", "marketing_start_date": "20070220"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-04)  / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "0280-6080-04", "marketing_start_date": "20221020"}, {"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16)", "package_ndc": "0280-6080-16", "marketing_start_date": "20070220"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "0280-6080-20", "marketing_start_date": "20070220"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-40)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "0280-6080-40", "marketing_start_date": "20070220"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-80)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "0280-6080-80", "marketing_start_date": "20070220"}], "brand_name": "Aleve", "product_id": "0280-6080_4526c253-b571-1d84-e063-6394a90ae3f9", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0280-6080", "generic_name": "Naproxen Sodium", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aleve", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "NDA021920", "marketing_category": "NDA", "marketing_start_date": "20070220", "listing_expiration_date": "20261231"}