Home NDC 50436-4464 Cialis
Product NDC 50436-4464
11-digit product format 504364464
Labeler code 50436
Product ID 50436-4464_6e973607-b0ac-459a-81e1-02d5c4970015
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unit Dose Services
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50436-4464-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50436-4464-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50436-4464-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50436-4464-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50436-4464-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50436-4464-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50436-4464-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50436-4464-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50436-4464-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50436-4464-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50436-4464-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50436-4464-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50436-4464-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50436-4464-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50436-4464-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50436-4464-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50436-4464-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50436-4464-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50436-4464-1 8dfbde2a14a4…c9ff85d89658…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 5 · 172 observed 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 2026-09-14 22:38:34 2026-08 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 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 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021368-004 CIALIS 2.5MG TABLET / ORAL RLD 2008-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021368-004 CIALIS 2.5MG TABLET / ORAL RLD 2008-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021368-004 CIALIS 2.5MG TABLET / ORAL RLD 2008-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021368-004 CIALIS 2.5MG TABLET / ORAL RLD 2008-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021368-004 CIALIS 2.5MG TABLET / ORAL RLD 2008-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021368-004 CIALIS 2.5MG TABLET / ORAL RLD 2008-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD 2003-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021368-002 CIALIS 10MG TABLET / ORAL AB1 RLD 2003-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021368-003 CIALIS 20MG TABLET / ORAL AB1 RLD, RS 2003-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021368-004 CIALIS 2.5MG TABLET / ORAL AB1 RLD 2008-01-07 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-4464-1 Cialis 30 in 1 BOTTLE TABLET, FILM COATED 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-4464 CIALIS (TADALAFIL) TABLET, FILM COATED [UNIT DOSE SERVICES] 6 Legacy NDC, 1 package rows 20190222_ee053358-9746-4475-9d3d-ca83ea84c125.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-4464-1 50436446401 30 in 1 BOTTLE Historical