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
- 68382-897_5a958db7-5c0e-4cf0-9227-230886cf9bf8
- Product NDC
- 68382-897
- Form
- TABLET, FILM COATED
- Composition / generic term
- Tadalafil
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20190327
- Source listing expiry
- 20261231
Source-listed ingredients
- TADALAFIL — 5 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 100 TABLET, FILM COATED in 1 BOTTLE (68382-897-01) · 68382-897-01
- 500 TABLET, FILM COATED in 1 BOTTLE (68382-897-05) · 68382-897-05
- 30 TABLET, FILM COATED in 1 BOTTLE (68382-897-06) · 68382-897-06
- 1000 TABLET, FILM COATED in 1 BOTTLE (68382-897-10) · 68382-897-10
- 90 TABLET, FILM COATED in 1 BOTTLE (68382-897-16) · 68382-897-16
- 10 TABLET, FILM COATED in 1 BOTTLE (68382-897-50) · 68382-897-50
- 2 BLISTER PACK in 1 CARTON (68382-897-99) / 15 TABLET, FILM COATED in 1 BLISTER PACK · 68382-897-99
Source and coverage
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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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