Home NDC 63629-4601-1 Cialis
Product NDC 63629-4601
Requested package NDC 63629-4601-1
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 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RS 2003-11-21 N021368-004 CIALIS TADALAFIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07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N021368-004 CIALIS 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07 a50c72e98297…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# 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
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