naproxen

Generic: naproxen

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler st. mary's medical park pharmacy
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-644
Product ID 60760-644_48ec9044-5bd0-1635-e063-6394a90a33c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212517
Listing Expiration 2027-12-31
Marketing Start 2022-07-11

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 60760644
Hyphenated Format 60760-644

Supplemental Identifiers

RxCUI
198012
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

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 ANDA212517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (60760-644-20)
  • 60 TABLET in 1 BOTTLE, PLASTIC (60760-644-60)
source: ndc

Packages (2)

Ingredients (1)

naproxen (375 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "48ec9044-5bd0-1635-e063-6394a90a33c0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012"], "spl_set_id": ["e3a4ab4a-b109-eb5e-e053-2a95a90afddd"], "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": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (60760-644-20)", "package_ndc": "60760-644-20", "marketing_start_date": "20220711"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (60760-644-60)", "package_ndc": "60760-644-60", "marketing_start_date": "20250317"}], "brand_name": "Naproxen", "product_id": "60760-644_48ec9044-5bd0-1635-e063-6394a90a33c0", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60760-644", "generic_name": "Naproxen", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA212517", "marketing_category": "ANDA", "marketing_start_date": "20220711", "listing_expiration_date": "20271231"}