Home NDC 50436-0033-5 Sildenafil
Product NDC 50436-0033
Requested package NDC 50436-0033-5
11-digit product format 504360033
Labeler code 50436
Product ID 50436-0033_3017ecea-bcb6-4c5a-a066-5944b4ef24e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unit Dose Services
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50436-0033-1 2023-01-30 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-2 2023-01-30 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-3 2023-01-30 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-4 2023-01-30 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-5 2023-01-30 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-1 2021-02-16 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-2 2021-02-16 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-3 2021-02-16 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-4 2021-02-16 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-5 2021-02-16 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-1 2021-01-29 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-2 2021-01-29 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-3 2021-01-29 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-4 2021-01-29 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998 50436-0033-5 2021-01-29 These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Initial U.S. Approval: 1998
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-0033-1 Sildenafil 1890 in 1 CASE TABLET, FILM COATED 1890 3 50436-0033-1 Sildenafil 1 in 1 POUCH TABLET, FILM COATED 1 3 50436-0033-2 Sildenafil 1620 in 1 CASE TABLET, FILM COATED 1620 3 50436-0033-2 Sildenafil 2 in 1 POUCH TABLET, FILM COATED 2 3 50436-0033-3 Sildenafil 1620 in 1 CASE TABLET, FILM COATED 1620 3 50436-0033-3 Sildenafil 3 in 1 POUCH TABLET, FILM COATED 3 3 50436-0033-4 Sildenafil 4 in 1 POUCH TABLET, FILM COATED 4 3 50436-0033-4 Sildenafil 1350 in 1 CASE TABLET, FILM COATED 1350 3 50436-0033-5 Sildenafil 1350 in 1 CASE TABLET, FILM COATED 1350 3 50436-0033-5 Sildenafil 5 in 1 POUCH TABLET, FILM COATED 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-0033 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [UNIT DOSE SERVICES] 3 Legacy NDC, 10 package rows 20210217_f2abd969-5ff1-413b-80ab-5e3939116877.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 Units Marketing start Marketing end Sample Exclude flag Status 50436-0033-5 50436003305 1350 POUCH in 1 CASE (50436-0033-5) > 5 TABLET, FILM COATED in 1 POUCH 1350 pouch 2021-02-16 0000-00-00 No No Current