Home NDC 43063-550 Sildenafil
Product NDC 43063-550
11-digit product format 430630550
Labeler code 43063
Product ID 43063-550_cb07ad88-11df-ddce-e053-2995a90aaf8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
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 2022-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43063-550-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43063-550-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43063-550-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43063-550-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43063-550-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43063-550-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43063-550-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43063-550-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43063-550-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43063-550-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43063-550-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43063-550-10 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 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…2022-09-29 23:25 UTC 2022-09 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book exclusivity history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SILDENAFIL CITRATE ACTIVE INGREDIENT BW9B0ZE037 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 SILDENAFIL ACTIVE MOIETY 3M7OB98Y7H SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43063-550-10 43063055010 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-550-10) 2014-10-29 0000-00-00 No No Current