Home NDC 0480-9277 ALYQ
Product NDC 0480-9277
11-digit product format 004809277
Labeler code 0480
Product ID 0480-9277_bb19ac7a-7882-4715-87e0-7bf1c30f1c62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA216932
Marketing category ANDA
Marketing start 2024-02-20
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 A216932-001 ALYQ TADALAFIL 20MG TABLET / ORAL AB2 2022-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216932-001 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.
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 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216932-001 ALYQ 20MG TABLET / ORAL 2022-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216932-001 ALYQ 20MG TABLET / ORAL 2022-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216932-001 ALYQ 20MG TABLET / ORAL 2022-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216932-001 ALYQ 20MG TABLET / ORAL AB2 2022-10-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ALYQ
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2110455 Internal RxNorm lookup 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 0480-9277-06 ALYQ 60 in 1 BOTTLE TABLET, FILM COATED 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-9277 ALYQ (TADALAFIL) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] 5 Current NDC, 1 package rows 20250105_2faa7a55-3054-456b-8465-6ea6dc1c0aa9.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 Sample Exclude flag Status 0480-9277-06 00480927706 60 TABLET, FILM COATED in 1 BOTTLE (0480-9277-06) 2024-02-20 No No Current