Home NDC 53217-293 Sildenafil
Product NDC 53217-293
11-digit product format 532170293
Labeler code 53217
Product ID 53217-293_d7c2ba37-8904-4395-ac23-85d29efefe9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA203963
Marketing category ANDA
Marketing start 2015-11-18
Marketing end 0000-00-00
Substance SILDENAFIL CITRATE
Active strength 20 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203963-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203963-001 AB
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 · 44 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 2026-10-15 13:18:30 2026-09 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A203963-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203963-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203963-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203963-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53217-293-10 Sildenafil 10 in 1 BOTTLE TABLET, FILM COATED 10 1 53217-293-90 Sildenafil 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53217-293 SILDENAFIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 2 package rows 20170511_c290dc6b-ecb6-4e5f-b45a-4b18217bf325.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53217-293-10 53217029310 10 in 1 BOTTLE Historical 53217-293-90 53217029390 90 in 1 BOTTLE Historical