Home NDC 0378-1660-93 Sildenafil
Product NDC 0378-1660
Requested package NDC 0378-1660-93
11-digit product format 003781660
Labeler code 0378
Product ID 0378-1660_1d0e6262-2e9e-43ca-8f44-5f7e202a662c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA201171
Marketing category ANDA
Marketing start 2019-04-04
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 2020-12-31
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 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-1660 0378-1660-93 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-1660 SILDENAFIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 Legacy NDC 20250215_cad6e3ac-84e5-4dae-9c26-8f6078f0da0c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-1660-93 00378166093 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1660-93) 2019-04-04 0000-00-00 No No Current