Home NDC 43353-345 Sildenafil
Product NDC 43353-345
11-digit product format 433530345
Labeler code 43353
Product ID 43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA021845
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-09-27
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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N021845-001 REVATIO SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021845-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N021845-001 M-287 2026-01-31 N021845-001 ODE-469 2030-01-31
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 · 43 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 2026-09-14 22:38:34 2026-08 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 42 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-345-10 Sildenafil 10 in 1 BOTTLE TABLET, FILM COATED 10 1 43353-345-20 Sildenafil 20 in 1 BOTTLE TABLET, FILM COATED 20 1 43353-345-53 Sildenafil 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-345 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 3 package rows 20170706_761f9606-2583-439a-a29e-736008340a9e.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 Marketing start Marketing end Sample Exclude flag Status 43353-345-10 43353034510 10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10) 2017-07-03 0000-00-00 No No Current 43353-345-20 43353034520 20 TABLET, FILM COATED in 1 BOTTLE (43353-345-20) 2017-07-03 0000-00-00 No No Current 43353-345-53 43353034553 60 TABLET, FILM COATED in 1 BOTTLE (43353-345-53) 2017-07-03 0000-00-00 No No Current