Home NDC 48792-7912 Sildenafil
Product NDC 48792-7912
11-digit product format 487927912
Labeler code 48792
Product ID 48792-7912_a8a33461-e732-e4a9-e053-2995a90a42bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sunshine Lake Pharma Co., Ltd
Application ANDA213032
Marketing category ANDA
Marketing start 2020-06-11
Marketing end 0000-00-00
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 2021-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213032-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 A213032-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 A213032-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11
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 3 · 111 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 2026-02-19 14:30 UTC 2026-02 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213032-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213032-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213032-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-11 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
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 Marketing end Sample Exclude flag Status 48792-7912-1 48792791201 30 TABLET, FILM COATED in 1 BOTTLE (48792-7912-1) 2020-06-11 0000-00-00 No No Current 48792-7912-2 48792791202 100 TABLET, FILM COATED in 1 BOTTLE (48792-7912-2) 2020-06-11 0000-00-00 No No Current