Home NDC 0480-2309 Tadalafil
Product NDC 0480-2309
11-digit product format 004802309
Labeler code 0480
Product ID 0480-2309_8406079c-f302-43d9-a7d7-5e790bde8c85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA205885
Marketing category ANDA
Marketing start 2024-01-16
Marketing end 2027-02-28
Substance TADALAFIL
Active strength 5 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0480-2309-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0480-2309-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0480-2309-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0480-2309-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0480-2309-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0480-2309-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0480-2309-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0480-2309-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0480-2309-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0480-2309-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0480-2309-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0480-2309-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0480-2309-00 d1e113ab4d42…063ee3eb0a1d…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A205885-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 A205885-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 A205885-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 A205885-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29
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.
Product history page 1 of 5 · 168 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 2026-08-18 06:07:40 2026-07 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205885-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-29 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tadalafil Active Ingredients# Ingredient, Strength table Ingredient Strength TADALAFIL 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402019 Internal RxNorm lookup 403957 Internal RxNorm lookup 484814 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 0480-2309-56 Tadalafil 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-2309 TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] 6 Current NDC, 1 package rows 20250519_3ad14d63-42e7-493f-b56c-e02a4fd139f7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0480-2309-56 00480230956 30 TABLET, FILM COATED in 1 BOTTLE (0480-2309-56) 2024-01-16 2027-02-28 No No Historical