Drug Database
Back to search

United States· US:49483-608_0538c5c7-c559-4ea9-e063-6294a90aec21

NAPROXEN SODIUM

A naproxen product containing naproxen sodium, registered in United States by TIME CAP LABORATORIES, INC. The same ATC class is registered in 15 of our 19 countries.

ATC M01AE02US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedNAPROXEN SODIUMATCM01AE02REGISTER NO.US:49483-608_0538c5c7…PACKS LISTED8CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about naproxen sodiumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Naproxen is registered in 15 of 19 countries.

Countries holding a registration under ATC M01AE02 (naproxen), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose
Search naproxen products by name

Naproxen · ATC M01AE02

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of naproxen costs, country by country.

Normalised to the WHO defined daily dose (0.5 g), the median price runs from $0.16 in Italy to $0.82 in Switzerland — a ×4.9 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Naproxen · price per daily dose (0.5 g)

USD · FX 28 Sept 2026

  • CH Switzerland$0.82
  • IT Italy$0.16
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
NAPROXEN SODIUM
Manufacturer
TIME CAP LABORATORIES, INC
Country
United States (US)
ATC code
M01AE02
ATC class
Naproxen
Defined daily dose
0.5 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 8

  • ndc11
    4948360800
    6500 TABLET, FILM COATED in 1 BAG (49483-608-00)
  • ndc11
    4948360801
    100 TABLET, FILM COATED in 1 BOTTLE (49483-608-01)
  • ndc11
    4948360805
    50 TABLET, FILM COATED in 1 BOTTLE (49483-608-05)
  • ndc11
    4948360831
    300 TABLET, FILM COATED in 1 BOTTLE (49483-608-31)
  • ndc11
    49483-608-00
  • ndc11
    49483-608-01
  • ndc11
    49483-608-05
  • ndc11
    49483-608-31

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

495 interactions on record for naproxen.

Graded by severity as the source publishes them — 58 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check naproxen against other medicinesHow interaction checks work

Naproxen · interactions on record

495 records

  • 58 severe
  • 176 moderate
  • 17 minor
  • 161 info

Most severe, free to view

  • DicoumarolB01AA01severe
  • WarfarinB01AA03severe
  • DalteparinB01AB04severe
  • EnoxaparinB01AB05severe

83 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Naproxen in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All naproxen products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Aleve, Miranax
  • Belgium · Aleve, Apranax
  • Bulgaria · Налгезин, Налгезин Форте
  • Cyprus · Naprorex, Priaxen
  • Czechia · Emoxen, Nalgesin
  • Germany · Aspidolo, Dolormin Für Frauen Bei Menstruationsbeschwerden Mit
  • Denmark · Bonyl, Naproxen Evolan
  • Estonia · Emox, Nalgesin Forte
  • Spain · Actromadol, Antalgin
  • Finland · Miranax, Naprometin
  • France · Aleve, Alevetabs
  • United Kingdom (Northern Ireland) · Almus Period Pain Reliever, Boots Period Pain Reliever
  • Greece · Anaprox, Naprosyn
  • Croatia · Nalgesin, Nalgesin Forte
  • Hungary · Aleve, Aleve Extra
  • Ireland · Naprosyn Ec, Naproxen Azure Pharmaceuticals
  • Iceland · Naproxen Viatris, Naproxen-E Viatris
  • Italy · Dololibre, Femmedol
  • Lithuania · Emox, Nalgesin Forte
  • Luxembourg · Aleve, Apranax
  • Latvia · Emox, Nalgedol
  • Malta · Naprorex, Naprosyn
  • Netherlands · Aleve Classic Bij Pijn En Koorts, Aleve Feminax Bij Menstruatiepijn
  • Norway · Napren-E, Naproxen Evolan
  • Poland · 4flex Puregel, Aleve
  • Portugal · Actronadol, Ilgesin
  • Romania · Mobilat Pro, Naldorex
  • Sweden · Ipaflex, Naprocur
  • Slovenia · Nalgesin, Nalgesin Forte
  • Slovakia · Emoxen Gél, Nalgesin Forte

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/b7823e33-efcc-4bc8-9a00-4ae9a119d5fd
GET /v1/drugs/b7823e33-efcc-4bc8-9a00-4ae9a119d5fd?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "220",
  "substance": "NAPROXEN SODIUM",
  "productndc": "49483-608",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA090545",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about naproxen.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

Try it freeOpen in the console