Home NDC 50268-738-13 Tadalafil
Product NDC 50268-738
Requested package NDC 50268-738-13
11-digit product format 502680738
Labeler code 50268
Product ID 50268-738_df22addc-06e7-9804-e053-2a95a90a6c3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvPAK
Application ANDA210069
Marketing category ANDA
Marketing start 2020-02-26
Marketing end 0000-00-00
Substance TADALAFIL
Active strength 5 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 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.
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 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A210069-004 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tadalafil TADALAFIL Dr.Reddys Laboratories Inc 22b8a2e3-d1b8-f193-45fa-77cc62a1b941 2020-01-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 210069 application number: ANDA210069
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-738 TADALAFIL TABLET, FILM COATED [AVPAK] 6 Legacy NDC 20250112_9f7dfabf-40dc-d433-e053-2a95a90ac784.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-738-13 50268073813 30 BLISTER PACK in 1 BOX (50268-738-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-738-11) 30 blister pack 2020-02-26 0000-00-00 No No Current