Home NDC 82009-080 Tadalafil
Product NDC 82009-080
11-digit product format 820090080
Labeler code 82009
Product ID 82009-080_f6dd0676-5e89-4c63-8a1c-7b594d23f304
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET
Route ORAL
Labeler Quallent Pharmaceuticals Health LLC
Application ANDA210392
Marketing category ANDA
Marketing start 2023-07-19
Substance TADALAFIL
Active strength 20 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210392-001 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210392-001 AB2
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 2 · 43 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 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210392-001 TADALAFIL 20MG TABLET / ORAL AB2 2019-02-05 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tadalafil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TADALAFIL 20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2123194 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 82009-080-60 Tadalafil 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82009-080 TADALAFIL TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] 1 Current NDC, 1 package rows 20230719_84cb16c8-30ab-49f2-a6df-ec3c97bf6284.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82009-080-60 82009008060 60 TABLET in 1 BOTTLE (82009-080-60) 60 tablet 2023-07-19 No No Current