Home NDC 33342-043 Sildenafil
Product NDC 33342-043
11-digit product format 333420043
Labeler code 33342
Product ID 33342-043_e89d523d-8d42-4bbf-be3d-2b15e7c15f4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA202255
Marketing category ANDA
Marketing start 2023-04-19
Substance SILDENAFIL CITRATE
Active strength 100 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202255-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 A202255-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 A202255-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19
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.
Product history page 1 of 2 · 69 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 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202255-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2023-04-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202255-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2023-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202255-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2023-04-19 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sildenafil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 100 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-043-07 Sildenafil 30 in 1 BOTTLE TABLET, FILM COATED 30 5 33342-043-11 Sildenafil 100 in 1 BOTTLE TABLET, FILM COATED 100 5 33342-043-44 Sildenafil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 5 33342-043-98 Sildenafil 1 in 1 CARTON TABLET, FILM COATED 1 5 33342-043-98 Sildenafil 60 in 1 BLISTER PACK TABLET, FILM COATED 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-043 SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 5 package rows 20230505_c2b25818-99a3-474b-a04c-929df1110834.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-043-07 33342004307 30 TABLET, FILM COATED in 1 BOTTLE (33342-043-07) 2023-04-19 No No Current 33342-043-11 33342004311 100 TABLET, FILM COATED in 1 BOTTLE (33342-043-11) 2023-04-19 No No Current 33342-043-44 33342004344 1000 TABLET, FILM COATED in 1 BOTTLE (33342-043-44) 2023-04-19 No No Current 33342-043-98 33342004398 1 BLISTER PACK in 1 CARTON (33342-043-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2023-04-19 No No Current