Home NDC 71205-509 Sildenafil
Product NDC 71205-509
11-digit product format 712050509
Labeler code 71205
Product ID 71205-509_72c1516f-8a0c-495c-b11f-93bdc574ad21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA078380
Marketing category ANDA
Marketing start 2013-05-31
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 2026-12-31
Current FDA listing Yes 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 A078380-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL 2013-01-07
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 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL 2013-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078380-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2013-01-07 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sildenafil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BW9B0ZE037 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577033 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71205-509-30 Sildenafil 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71205-509-60 Sildenafil 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71205-509-90 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 71205-509 SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP] 1 Current NDC, Legacy NDC, 3 package rows 20201201_72c1516f-8a0c-495c-b11f-93bdc574ad21.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.
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 71205-509-30 71205050930 30 TABLET, FILM COATED in 1 BOTTLE (71205-509-30) 2020-11-24 0000-00-00 No No Current 71205-509-60 71205050960 60 TABLET, FILM COATED in 1 BOTTLE (71205-509-60) 2020-11-24 0000-00-00 No No Current 71205-509-90 71205050990 90 TABLET, FILM COATED in 1 BOTTLE (71205-509-90) 2020-11-24 0000-00-00 No No Current