Home NDC 59762-2058 Sildenafil
Product NDC 59762-2058
11-digit product format 597622058
Labeler code 59762
Product ID 59762-2058_8f234077-0221-4a20-b115-23a9f061a402
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Greenstone LLC
Application NDA203109
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-09-11
Marketing end 0000-00-00
Substance SILDENAFIL CITRATE
Active strength 10 mg/mL
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 · 46 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 product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-2058-1 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-2058-1 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 product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-2058-1 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-2058-1 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 product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59762-2058-1 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59762-2058-1 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 product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59762-2058-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59762-2058-1 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 product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59762-2058-1 cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59762-2058-1 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 product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59762-2058-1 cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59762-2058-1 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 product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59762-2058-1 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59762-2058-1 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 product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59762-2058-1 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59762-2058-1 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 product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59762-2058-1 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59762-2058-1 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 product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59762-2058-1 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59762-2058-1 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 product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59762-2058-1 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59762-2058-1 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 59762-2058-1 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 N203109-001 REVATIO SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL RLD 2012-08-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203109-001 M-287 2026-01-31
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 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL RLD 2012-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB RLD, RS 2012-08-30 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-2058-1 Sildenafil 1 in 1 CARTON POWDER, FOR SUSPENSION 1 19 59762-2058-1 Sildenafil 112 mL in 1 BOTTLE POWDER, FOR SUSPENSION 112 19
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 [GREENSTONE LLC] 9 SILDENAFIL ACTIVE MOIETY 3M7OB98Y7H SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-2058 SILDENAFIL TABLET, FILM COATED SILDENAFIL POWDER, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.] 19 Legacy NDC, 2 package rows 20250503_56a962e8-de00-4a97-8904-0b1bd217dd83.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Revatio SILDENAFIL CITRATE Viatris Specialty LLC 3bb9363e-b28d-4019-8aae-539233dca214 2024-12-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 203109 application number: NDA203109
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 59762-2058-1 59762205801 1 BOTTLE in 1 CARTON (59762-2058-1) > 112 mL in 1 BOTTLE 1 bottle 2019-09-11 0000-00-00 No No Current