Home NDC 0591-4050 Sildenafil
Product NDC 0591-4050
11-digit product format 005914050
Labeler code 0591
Product ID 0591-4050_4c7d4ea0-d3b7-4a20-b5d6-09207153aaad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA211534
Marketing category ANDA
Marketing start 2020-08-17
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 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 A211534-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211534-001 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 2026-08-18 06:07:40 2026-07 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211534-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2020-05-29 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 CITRATE 10 mg/mL
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 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 0591-4050-94 Sildenafil 1 in 1 CARTON POWDER, FOR SUSPENSION 1 6 0591-4050-94 Sildenafil 112 mL in 1 BOTTLE POWDER, FOR SUSPENSION 112 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-4050 SILDENAFIL POWDER, FOR SUSPENSION [ACTAVIS PHARMA, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241108_0e6428c0-e0e9-4fc0-8615-6a9678d2286c.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 Units Marketing start Marketing end Sample Exclude flag Status 0591-4050-94 00591405094 1 BOTTLE in 1 CARTON (0591-4050-94) / 112 mL in 1 BOTTLE 1 bottle 2020-08-17 0000-00-00 No No Current