Home NDC 63629-4601 Cialis
Product NDC 63629-4601
11-digit product format 636294601
Labeler code 63629
Product ID 63629-4601_d8cc819c-3aa2-45a6-9828-61be5462c65d
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 5 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-4601-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-4601-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63629-4601-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63629-4601-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63629-4601-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63629-4601-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63629-4601-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63629-4601-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63629-4601-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63629-4601-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63629-4601-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-4601-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-4601-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TADALAFIL ACTIVE INGREDIENT 742SXX0ICT CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TADALAFIL ACTIVE MOIETY 742SXX0ICT CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TALC INACTIVE INGREDIENT 7SEV7J4R1U CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CIALIS (TADALAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-4601-1 63629460101 1 TABLET, FILM COATED in 1 BOTTLE (63629-4601-1) 2015-09-17 0000-00-00 No No Current