Home NDC 71610-213-12 Tadalafil
Product NDC 71610-213
Requested package NDC 71610-213-12
11-digit product format 716100213
Labeler code 71610
Product ID 71610-213_004c75b3-29f0-4e32-82fe-fec4ce0350d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA021368
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-09-27
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 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RS 2003-11-21 N021368-004 CIALIS TADALAFIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07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N021368-004 CIALIS 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-01-07 a50c72e98297…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
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-213 TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20190110_1621128d-56e9-48f0-876c-77081daa7f12.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71610-213-12 71610021312 12 TABLET, FILM COATED in 1 BOTTLE (71610-213-12) 2018-12-28 0000-00-00 No No Current