naproxen

Generic: naproxen

Labeler: trupharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler trupharma llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
TruPharma LLC

Identifiers & Regulatory

Product NDC 52817-380
Product ID 52817-380_28a0f21b-859f-0459-e063-6394a90a08e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216908
Listing Expiration 2026-12-31
Marketing Start 2023-07-27

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817380
Hyphenated Format 52817-380

Supplemental Identifiers

RxCUI
311915 603103
UPC
0352817380104 0352817381101
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

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 (source: ndc)
Application Number ANDA216908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52817-380-10)
source: ndc

Packages (1)

52817-380-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52817-380-10)

Ingredients (1)

naproxen (375 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": "28a0f21b-859f-0459-e063-6394a90a08e0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0352817380104", "0352817381101"], "unii": ["57Y76R9ATQ"], "rxcui": ["311915", "603103"], "spl_set_id": ["004bb832-29d5-add0-e063-6394a90a90f4"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["TruPharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52817-380-10)", "package_ndc": "52817-380-10", "marketing_start_date": "20230801"}], "brand_name": "Naproxen", "product_id": "52817-380_28a0f21b-859f-0459-e063-6394a90a08e0", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "52817-380", "generic_name": "Naproxen", "labeler_name": "TruPharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA216908", "marketing_category": "ANDA", "marketing_start_date": "20230727", "listing_expiration_date": "20261231"}