naproxen sodium

Generic: naproxen sodium

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen sodium 550 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-389
Product ID 72789-389_47a9b7b5-2b1d-7a8e-e063-6294a90a1f63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212199
Listing Expiration 2027-12-31
Marketing Start 2019-10-30

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 72789389
Hyphenated Format 72789-389

Supplemental Identifiers

RxCUI
849431
UPC
0372789389608
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 ANDA212199 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 550 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (72789-389-60)
source: ndc

Packages (1)

72789-389-60 60 TABLET in 1 BOTTLE, PLASTIC (72789-389-60)

Ingredients (1)

naproxen sodium (550 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": "47a9b7b5-2b1d-7a8e-e063-6294a90a1f63", "openfda": {"upc": ["0372789389608"], "unii": ["9TN87S3A3C"], "rxcui": ["849431"], "spl_set_id": ["145cdcc0-9bd5-4a0e-81fc-11a24d181980"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (72789-389-60)", "package_ndc": "72789-389-60", "marketing_start_date": "20240401"}], "brand_name": "Naproxen Sodium", "product_id": "72789-389_47a9b7b5-2b1d-7a8e-e063-6294a90a1f63", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72789-389", "generic_name": "Naproxen Sodium", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "550 mg/1"}], "application_number": "ANDA212199", "marketing_category": "ANDA", "marketing_start_date": "20191030", "listing_expiration_date": "20271231"}