naproxen

Generic: naproxen

Labeler: acella pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler acella pharmaceuticals, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

naproxen 125 mg/5mL

Manufacturer
Acella Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 42192-619
Product ID 42192-619_47a98b71-a338-b13d-e063-6394a90a96f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA018965
Marketing Start 2020-11-12
Marketing End 2028-01-31

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 42192619
Hyphenated Format 42192-619

Supplemental Identifiers

RxCUI
311913
UPC
0342192619166
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 NDA018965 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (42192-619-16)
source: ndc

Packages (1)

42192-619-16 473 mL in 1 BOTTLE (42192-619-16)

Ingredients (1)

naproxen (125 mg/5mL)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47a98b71-a338-b13d-e063-6394a90a96f6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0342192619166"], "unii": ["57Y76R9ATQ"], "rxcui": ["311913"], "spl_set_id": ["7e6f03fb-4b36-4418-9684-f45637abbb78"], "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": ["Acella Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (42192-619-16)", "package_ndc": "42192-619-16", "marketing_end_date": "20280131", "marketing_start_date": "20201112"}], "brand_name": "Naproxen", "product_id": "42192-619_47a98b71-a338-b13d-e063-6394a90a96f6", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "42192-619", "generic_name": "Naproxen", "labeler_name": "Acella Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "125 mg/5mL"}], "application_number": "NDA018965", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20280131", "marketing_start_date": "20201112"}