Home NDC 70954-435 Tadalafil
Product NDC 70954-435
11-digit product format 709540435
Labeler code 70954
Product ID 70954-435_1dace1e7-c617-492f-bb0d-141bf4e673db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA215949
Marketing category ANDA
Marketing start 2023-03-06
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215949-001 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 A215949-002 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 A215949-003 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03
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.
Product history page 1 of 2 · 75 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 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215949-002 TADALAFIL 10MG TABLET / ORAL AB1 2023-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215949-003 TADALAFIL 20MG TABLET / ORAL AB1 2023-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215949-001 TADALAFIL 5MG TABLET / ORAL AB1 2023-03-03 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 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 · 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 70954-435-10 Tadalafil 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-435 TADALAFIL TABLET [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20230309_1dace1e7-c617-492f-bb0d-141bf4e673db.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 Units Marketing start Sample Exclude flag Status 70954-435-10 70954043510 30 TABLET in 1 BOTTLE (70954-435-10) 30 tablet 2023-03-06 No No Current