Home NDC 0002-4465 Cialis
Product NDC 0002-4465
11-digit product format 000024465
Labeler code 0002
Product ID 0002-4465_05dbd8b6-1b9d-436a-a67c-8a16713f753f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Eli Lilly and Company
Application NDA021368
Marketing category NDA
Marketing start 2008-01-07
Marketing end 0000-00-00
Substance TADALAFIL
Active strength 3 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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RS 2003-11-21 N021368-004 CIALIS TADALAFIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07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N021368-004 CIALIS 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021368-001 CIALIS 5MG TABLET / ORAL AB1 RLD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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tadalafil ACTIVE INGREDIENT 742SXX0ICT CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Tadalafil ACTIVE MOIETY 742SXX0ICT CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Hydroxypropyl cellulose (Type H) INACTIVE INGREDIENT RFW2ET671P CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Talc INACTIVE INGREDIENT 7SEV7J4R1U CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33 Triacetin INACTIVE INGREDIENT XHX3C3X673 CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 33
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-4465 CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY] 49 Legacy NDC 20241215_bcd8f8ab-81a2-4891-83db-24a0b0e25895.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 Units Marketing start Marketing end Sample Exclude flag Status 0002-4465-34 00002446534 2 BLISTER PACK in 1 CARTON (0002-4465-34) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0002-4465-79) 2 blister pack 2008-01-07 0000-00-00 No No Current