naproxen

Generic: naproxen sodium

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen sodium
Labeler amerisource bergen
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-564
Product ID 46122-564_df535323-45f6-489b-81fe-009ca024499d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204872
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

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 46122564
Hyphenated Format 46122-564

Supplemental Identifiers

RxCUI
849574
UPC
0087701431616
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 naproxen (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA204872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (46122-564-71) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (46122-564-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46122-564-81)
source: ndc

Packages (3)

46122-564-71 1 BOTTLE, PLASTIC in 1 CARTON (46122-564-71) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 46122-564-78 1 BOTTLE, PLASTIC in 1 CARTON (46122-564-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 46122-564-81 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46122-564-81)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df535323-45f6-489b-81fe-009ca024499d", "openfda": {"upc": ["0087701431616"], "unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0"], "manufacturer_name": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (46122-564-71)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "46122-564-71", "marketing_start_date": "20190201"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (46122-564-78)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "46122-564-78", "marketing_start_date": "20190201"}, {"sample": false, "description": "200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46122-564-81)", "package_ndc": "46122-564-81", "marketing_start_date": "20190201"}], "brand_name": "Naproxen", "product_id": "46122-564_df535323-45f6-489b-81fe-009ca024499d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "46122-564", "generic_name": "Naproxen Sodium", "labeler_name": "Amerisource Bergen", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA204872", "marketing_category": "ANDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}