United States · FDA National Drug Code directory

Roflumilast

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: 59746-802_809a91bb-96a4-49d7-9936-a8805a60ac5b
Product NDC: 59746-802
Form: TABLET
Composition / generic term: roflumilast
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Marketing category: ANDA
Marketing start / end (source format): 20260202
Source listing expiry: 20271231

Source-listed ingredients

ROFLUMILAST — 500 ug/1

These values do not establish equivalence or a dose recommendation.

Packages

500 TABLET in 1 BOTTLE (59746-802-05) · 59746-802-05
30 TABLET in 1 BOTTLE (59746-802-30) · 59746-802-30
90 TABLET in 1 BOTTLE (59746-802-90) · 59746-802-90

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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