Home NDC 69238-1574 Sildenafil
Product NDC 69238-1574
11-digit product format 692381574
Labeler code 69238
Product ID 69238-1574_87224b5f-b3ee-40e4-8ac1-45356a1b86eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA211092
Marketing category ANDA
Marketing start 2019-12-06
Substance SILDENAFIL
Active strength 10 mg/mL
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 1 .
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 A211092-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211092-001 AB
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.
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 2026-02-19 14:30 UTC 2026-02 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211092-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2019-11-27 a50c72e98297…
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 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3M7OB98Y7H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1307427 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 69238-1574-1 Sildenafil 112 mL in 1 BOTTLE, GLASS POWDER, FOR SUSPENSION 112 18 69238-1574-1 Sildenafil 1 in 1 CARTON POWDER, FOR SUSPENSION 1 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1574 SILDENAFIL POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC] 18 Current NDC, Legacy NDC, 2 package rows 20240118_9de84092-ebe6-436c-a925-88a6e3861eba.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 69238-1574-1 69238157401 1 BOTTLE, GLASS in 1 CARTON (69238-1574-1) / 112 mL in 1 BOTTLE, GLASS 2019-12-06 0000-00-00 No No Current