Home NDC 24979-727 Tadalafil
Product NDC 24979-727
11-digit product format 249790727
Labeler code 24979
Product ID 24979-727_555edf7e-85bf-492f-8e14-c53f72aa5b38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA210420
Marketing category ANDA
Marketing start 2024-04-07
Substance TADALAFIL
Active strength 2.5 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A210420-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 A210420-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 A210420-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 A210420-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 A210420-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A210420-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A210420-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A210420-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Tadalafil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TADALAFIL 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 742SXX0ICT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402019 Internal RxNorm lookup 403957 Internal RxNorm lookup 484814 Internal RxNorm lookup 757707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24979-727-02 Tadalafil 500 in 1 BOTTLE TABLET, FILM COATED 500 3 24979-727-06 Tadalafil 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24979-727 TADALAFIL TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] 2 Current NDC, 2 package rows 20241208_ae801b15-0462-44af-99a4-affe3eed899a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 24979-727-02 24979072702 500 TABLET, FILM COATED in 1 BOTTLE (24979-727-02) 2024-04-07 No No Current 24979-727-06 24979072706 30 TABLET, FILM COATED in 1 BOTTLE (24979-727-06) 2024-04-07 No No Current