Home NDC 82647-210 Sildenafil
Product NDC 82647-210
11-digit product format 826470210
Labeler code 82647
Product ID 82647-210_49fd0cc5-980e-c7d1-e063-6394a90a85c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Reyoung Corporation
Application ANDA208494
Marketing category ANDA
Marketing start 2022-03-28
Substance SILDENAFIL CITRATE
Active strength 25 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 82647-210 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 82647-210 82647-210-14 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 82647-210 82647-210-30 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208494-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 A208494-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 A208494-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 114 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 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208494-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-06-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208494-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208494-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-06-12 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sildenafil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 25 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312950 Internal RxNorm lookup 314228 Internal RxNorm lookup 314229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82647-210-14 Sildenafil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3 82647-210-30 Sildenafil 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82647-210 SILDENAFIL TABLET, FILM COATED [REYOUNG CORPORATION] 2 Current NDC, Legacy NDC, 2 package rows 20240417_dc998a9c-0770-111b-e053-2a95a90a88a4.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 82647-210-14 82647021014 1000 TABLET, FILM COATED in 1 BOTTLE (82647-210-14) 2022-03-28 0000-00-00 No No Current 82647-210-30 82647021030 30 TABLET, FILM COATED in 1 BOTTLE (82647-210-30) 2022-03-28 0000-00-00 No No Current