Home NDC 46708-177 Tadalafil
Product NDC 46708-177
11-digit product format 467080177
Labeler code 46708
Product ID 46708-177_53d81162-1774-48a1-b19b-f2b0e2d1020a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tadalafil
Dosage form TABLET, COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA204809
Marketing category ANDA
Marketing start 2019-03-26
Substance TADALAFIL
Active strength 2.5 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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A204809-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A204809-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A204809-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A204809-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Tadalafil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TADALAFIL 2.5 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 · 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 46708-177-15 Tadalafil 30 in 1 CARTON TABLET, COATED 30 5 46708-177-31 Tadalafil 30 in 1 BOTTLE TABLET, COATED 30 5 46708-177-71 Tadalafil 500 in 1 BOTTLE TABLET, COATED 500 5 46708-177-91 Tadalafil 1000 in 1 BOTTLE TABLET, COATED 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-177 TADALAFIL TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED] 5 Current NDC, Legacy NDC, 4 package rows 20240906_741102c1-8809-44d4-9098-3dc8c0604764.zip
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 46708-177-15 46708017715 30 TABLET, COATED in 1 CARTON (46708-177-15) 2019-03-26 0000-00-00 No No Current 46708-177-31 46708017731 30 TABLET, COATED in 1 BOTTLE (46708-177-31) 2021-12-03 0000-00-00 No No Current 46708-177-71 46708017771 500 TABLET, COATED in 1 BOTTLE (46708-177-71) 2024-08-02 No No Current 46708-177-91 46708017791 1000 TABLET, COATED in 1 BOTTLE (46708-177-91) 2024-08-02 No No Current