Home NDC 62332-180 Tadalafil
Product NDC 62332-180
11-digit product format 623320180
Labeler code 62332
Product ID 62332-180_76b22a5c-175e-433e-bd1e-5fefb0a78d5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tadalafil
Dosage form TABLET, COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA204809
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 43 .
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 A204809-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 A204809-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 A204809-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 A204809-004 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 · 172 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 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 62332-180-30 Tadalafil 30 in 1 BOTTLE TABLET, COATED 30 14 62332-180-71 Tadalafil 500 in 1 BOTTLE TABLET, COATED 500 14 62332-180-91 Tadalafil 1000 in 1 BOTTLE TABLET, COATED 1000 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-180 TADALAFIL TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 14 Current NDC, Legacy NDC, 3 package rows 20250430_abcb2cda-9b3f-45f6-ad5f-c2370b0dd114.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 Marketing start Marketing end Sample Exclude flag Status 62332-180-30 62332018030 30 TABLET, COATED in 1 BOTTLE (62332-180-30) 2019-03-26 0000-00-00 No No Current 62332-180-71 62332018071 500 TABLET, COATED in 1 BOTTLE (62332-180-71) 2024-08-02 No No Current 62332-180-91 62332018091 1000 TABLET, COATED in 1 BOTTLE (62332-180-91) 2024-08-02 No No Current