naproxen sodium

Generic: naproxen sodium

Labeler: chain drug marketing association
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler chain drug marketing association
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Chain Drug Marketing Association

Identifiers & Regulatory

Product NDC 63868-466
Product ID 63868-466_459b1f3a-7730-da84-e063-6294a90ad9c5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079096
Marketing Start 2009-06-19
Marketing End 2028-01-31

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 63868466
Hyphenated Format 63868-466

Supplemental Identifiers

RxCUI
849574
UPC
0635515974562
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 sodium (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA079096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-25) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

63868-466-01 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 63868-466-25 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-25) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 63868-466-50 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC

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": "459b1f3a-7730-da84-e063-6294a90ad9c5", "openfda": {"upc": ["0635515974562"], "unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["2ee83008-c012-48d6-9479-65e7d6f50f4c"], "manufacturer_name": ["Chain Drug Marketing Association"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63868-466-01)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "63868-466-01", "marketing_end_date": "20280131", "marketing_start_date": "20090619"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63868-466-25)  / 24 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "63868-466-25", "marketing_end_date": "20270930", "marketing_start_date": "20130502"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63868-466-50)  / 50 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "63868-466-50", "marketing_end_date": "20270930", "marketing_start_date": "20090619"}], "brand_name": "Naproxen Sodium", "product_id": "63868-466_459b1f3a-7730-da84-e063-6294a90ad9c5", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63868-466", "generic_name": "NAPROXEN SODIUM", "labeler_name": "Chain Drug Marketing Association", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA079096", "marketing_category": "ANDA", "marketing_end_date": "20280131", "marketing_start_date": "20090619"}