United States · FDA National Drug Code directory

tadalafil

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
35573-460_da1eee2b-ebe6-4af3-ad52-2b349a360a9a
Product NDC
35573-460
Form
TABLET, FILM COATED
Composition / generic term
Tadalafil
Labeler
Burel Pharmaceuticals, LLC
Marketing category
ANDA
Marketing start / end (source format)
20230401
Source listing expiry
20271231

Source-listed ingredients

  • TADALAFIL — 2.5 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 15 CARTON in 1 BLISTER PACK (35573-460-56) / 30 TABLET, FILM COATED in 1 CARTON (35573-460-38) · 35573-460-56

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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