Home NDC 59746-435 Sildenafil
Product NDC 59746-435
11-digit product format 597460435
Labeler code 59746
Product ID 59746-435_4bcef8ac-9715-407e-a23c-ed036c8827c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA201156
Marketing category ANDA
Marketing start 2026-09-01
Substance SILDENAFIL CITRATE
Active strength 50 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A201156-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 A201156-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 A201156-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20
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.
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 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201156-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2024-12-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201156-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2024-12-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201156-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2024-12-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 Sildenafil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BW9B0ZE037 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312950 Internal RxNorm lookup 314228 Internal RxNorm lookup 314229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59746-435-01 59746043501 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-435-01) 2026-09-01 No No Current 59746-435-03 59746043503 100 TABLET, FILM COATED in 1 CARTON (59746-435-03) 2026-09-01 No No Current 59746-435-04 59746043504 10 TABLET, FILM COATED in 1 BLISTER PACK (59746-435-04) 2026-09-01 No No Current 59746-435-05 59746043505 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-435-05) 2026-09-01 No No Current 59746-435-30 59746043530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-435-30) 2026-09-01 No No Current 59746-435-90 59746043590 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-435-90) 2026-09-01 No No Current