naproxen

Generic: naproxen

Labeler: radha pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler radha pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 250 mg/1

Manufacturer
Radha Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 77771-434
Product ID 77771-434_09abd331-76e6-4d67-e063-6394a90ae75d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212517
Listing Expiration 2026-12-31
Marketing Start 2021-06-04

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 77771434
Hyphenated Format 77771-434

Supplemental Identifiers

RxCUI
198012 198013 198014
UPC
0377771436056 0377771434014 0377771434052 0377771435059 0377771435011 0377771436018
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 ANDA212517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (77771-434-01)
  • 500 TABLET in 1 BOTTLE (77771-434-05)
source: ndc

Packages (2)

77771-434-01 100 TABLET in 1 BOTTLE (77771-434-01) 77771-434-05 500 TABLET in 1 BOTTLE (77771-434-05)

Ingredients (1)

naproxen (250 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": "09abd331-76e6-4d67-e063-6394a90ae75d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0377771436056", "0377771434014", "0377771434052", "0377771435059", "0377771435011", "0377771436018"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170"], "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": ["Radha Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (77771-434-01)", "package_ndc": "77771-434-01", "marketing_start_date": "20210604"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (77771-434-05)", "package_ndc": "77771-434-05", "marketing_start_date": "20210604"}], "brand_name": "Naproxen", "product_id": "77771-434_09abd331-76e6-4d67-e063-6394a90ae75d", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "77771-434", "generic_name": "Naproxen", "labeler_name": "Radha Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "250 mg/1"}], "application_number": "ANDA212517", "marketing_category": "ANDA", "marketing_start_date": "20210604", "listing_expiration_date": "20261231"}