Home NDC 68788-7775 Sildenafil
Product NDC 68788-7775
11-digit product format 687887775
Labeler code 68788
Product ID 68788-7775_7bd0ca0d-0cd9-4504-a061-e98d8109e564
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA201171
Marketing category ANDA
Marketing start 2020-08-24
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A201171-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL 2019-03-25 A201171-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL 2019-03-25 A201171-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL 2019-03-25
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 4 · 126 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 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL 2019-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL 2019-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL 2019-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL 2019-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL 2019-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL 2019-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL 2019-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL 2019-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL 2019-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201171-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2019-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201171-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2019-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201171-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2019-03-25 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68788-7775-3 2022-02-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-4 2022-02-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-6 2022-02-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-7 2022-02-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-9 2022-02-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-3 2022-01-28 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-4 2022-01-28 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-6 2022-01-28 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-7 2022-01-28 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 68788-7775-9 2022-01-28 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-7775-3 68788777503 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7775-3) 2020-08-24 0000-00-00 No No Current 68788-7775-4 68788777504 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7775-4) 2020-08-24 0000-00-00 No No Current 68788-7775-6 68788777506 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7775-6) 2020-08-24 0000-00-00 No No Current 68788-7775-7 68788777507 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7775-7) 2020-08-24 0000-00-00 No No Current 68788-7775-9 68788777509 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7775-9) 2020-08-24 0000-00-00 No No Current