Home NDC 63629-7145-3 Cialis
Product NDC 63629-7145
Requested package NDC 63629-7145-3
11-digit product format 636297145
Labeler code 63629
Product ID 63629-7145_aeec0070-d017-4d16-94f2-e82765e77583
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA021368
Marketing category NDA
Marketing start 2003-11-26
Marketing end 0000-00-00
Substance TADALAFIL
Active strength 20 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021368-001 CIALIS TADALAFIL 5MG TABLET / ORAL AB1 RLD 2003-11-21 N021368-002 CIALIS TADALAFIL 10MG TABLET / ORAL AB1 RLD 2003-11-21 N021368-003 CIALIS TADALAFIL 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 N021368-004 CIALIS TADALAFIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N021368-004 CIALIS 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cialis TADALAFIL Eli Lilly and Company bcd8f8ab-81a2-4891-83db-24a0b0e25895 2026-06-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 021368 application number: NDA021368
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 63629-7145-1 2020-10-16 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003 63629-7145-2 2020-10-16 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003 63629-7145-3 2020-10-16 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003 63629-7145-4 2020-10-16 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003 63629-7145-1 2020-01-31 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003 63629-7145-2 2020-01-31 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003 63629-7145-3 2020-01-31 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003 63629-7145-4 2020-01-31 C162847 48780-1 9d75b9d0-aef4-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-7145-3 63629714503 10 TABLET, FILM COATED in 1 BOTTLE (63629-7145-3) 2016-11-29 0000-00-00 No No Current