Home NDC 43598-573 Tadalafil
Product NDC 43598-573
11-digit product format 435980573
Labeler code 43598
Product ID 43598-573_7d8af9db-e459-1195-41b8-67f96e390ef2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr.Reddys Laboratories Inc
Application ANDA210069
Marketing category ANDA
Marketing start 2019-03-26
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 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 A210069-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 A210069-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 A210069-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 A210069-004 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.
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 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
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 · 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 43598-573-30 Tadalafil 30 in 1 BOTTLE TABLET, FILM COATED 30 8 43598-573-31 Tadalafil 3 in 1 CARTON TABLET, FILM COATED 3 8 43598-573-60 Tadalafil 60 in 1 BOTTLE TABLET, FILM COATED 60 8 43598-573-79 Tadalafil 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-573 TADALAFIL TABLET, FILM COATED [DR.REDDYS LABORATORIES INC] 8 Current NDC, Legacy NDC, 4 package rows 20211130_22b8a2e3-d1b8-f193-45fa-77cc62a1b941.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 Marketing end Sample Exclude flag Status 43598-573-30 43598057330 30 TABLET, FILM COATED in 1 BOTTLE (43598-573-30) 2019-03-26 0000-00-00 No No Current 43598-573-31 43598057331 3 BLISTER PACK in 1 CARTON (43598-573-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-573-79) 3 blister pack 2020-04-07 0000-00-00 No No Current 43598-573-60 43598057360 60 TABLET, FILM COATED in 1 BOTTLE (43598-573-60) 2019-03-26 0000-00-00 No No Current 43598-573-79 43598057379 10 in 1 BLISTER PACK Historical