naproxen sodium

Generic: naproxen sodium

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler sam's west inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
SAM'S WEST INC

Identifiers & Regulatory

Product NDC 68196-255
Product ID 68196-255_8f4b0483-1a09-88f8-d289-faed40edd37c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075168
Listing Expiration 2026-12-31
Marketing Start 1998-07-29

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 68196255
Hyphenated Format 68196-255

Supplemental Identifiers

RxCUI
849574
UNII
9TN87S3A3C

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 sodium (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA075168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 400 TABLET, COATED in 1 BOTTLE (68196-255-20)
  • 400 TABLET, COATED in 1 BOTTLE (68196-255-40)
source: ndc

Packages (2)

68196-255-20 400 TABLET, COATED in 1 BOTTLE (68196-255-20) 68196-255-40 400 TABLET, COATED in 1 BOTTLE (68196-255-40)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f4b0483-1a09-88f8-d289-faed40edd37c", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["7a87a339-4482-ec9e-3c77-7ccb9cea2c4c"], "manufacturer_name": ["SAM'S WEST INC"]}, "finished": true, "packaging": [{"sample": false, "description": "400 TABLET, COATED in 1 BOTTLE (68196-255-20)", "package_ndc": "68196-255-20", "marketing_start_date": "20230301"}, {"sample": false, "description": "400 TABLET, COATED in 1 BOTTLE (68196-255-40)", "package_ndc": "68196-255-40", "marketing_start_date": "20250501"}], "brand_name": "Naproxen Sodium", "product_id": "68196-255_8f4b0483-1a09-88f8-d289-faed40edd37c", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68196-255", "generic_name": "Naproxen Sodium", "labeler_name": "SAM'S WEST INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA075168", "marketing_category": "ANDA", "marketing_start_date": "19980729", "listing_expiration_date": "20261231"}