berkley and jensen naproxen sodium

Generic: naproxen sodium

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name berkley and jensen naproxen sodium
Generic Name naproxen sodium
Labeler bjwc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-368
Product ID 68391-368_1d371cd3-2938-4ed8-b820-ec37c1017045
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074661
Listing Expiration 2026-12-31
Marketing Start 2007-09-17

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 68391368
Hyphenated Format 68391-368

Supplemental Identifiers

RxCUI
849574
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 berkley and jensen naproxen sodium (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA074661 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 400 TABLET, FILM COATED in 1 BOTTLE (68391-368-79)
source: ndc

Packages (1)

68391-368-79 400 TABLET, FILM COATED in 1 BOTTLE (68391-368-79)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Berkley and Jensen Naproxen Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d371cd3-2938-4ed8-b820-ec37c1017045", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["9530b649-3e01-452c-99a6-cff47fa4085b"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "400 TABLET, FILM COATED in 1 BOTTLE (68391-368-79)", "package_ndc": "68391-368-79", "marketing_start_date": "20110415"}], "brand_name": "Berkley and Jensen Naproxen Sodium", "product_id": "68391-368_1d371cd3-2938-4ed8-b820-ec37c1017045", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68391-368", "generic_name": "Naproxen Sodium", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Berkley and Jensen Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA074661", "marketing_category": "ANDA", "marketing_start_date": "20070917", "listing_expiration_date": "20261231"}