Home NDC 71335-0969 Sildenafil
Product NDC 71335-0969
11-digit product format 713350969
Labeler code 71335
Product ID 71335-0969_d1050818-e0b0-4be8-88c3-80e4a20e5250
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202023
Marketing category ANDA
Marketing start 2018-06-28
Substance SILDENAFIL CITRATE
Active strength 100 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 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A202023-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 A202023-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 A202023-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27
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 4 · 126 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 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202023-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2018-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202023-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2018-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202023-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2018-06-27 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sildenafil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 100 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 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# NDC, Effective, Related label table NDC Effective Related label 71335-0969-0 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-1 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-2 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-3 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-4 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-5 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-6 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-7 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-8 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-9 2024-05-17 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-0 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-1 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-2 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-3 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-4 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-5 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-6 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-7 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-8 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998 71335-0969-9 2024-01-30 These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0969-0 Sildenafil 15 in 1 BOTTLE TABLET, FILM COATED 15 7 71335-0969-1 Sildenafil 10 in 1 BOTTLE TABLET, FILM COATED 10 7 71335-0969-2 Sildenafil 5 in 1 BOTTLE TABLET, FILM COATED 5 7 71335-0969-3 Sildenafil 30 in 1 BOTTLE TABLET, FILM COATED 30 7 71335-0969-4 Sildenafil 2 in 1 BOTTLE TABLET, FILM COATED 2 7 71335-0969-5 Sildenafil 6 in 1 BOTTLE TABLET, FILM COATED 6 7 71335-0969-6 Sildenafil 20 in 1 BOTTLE TABLET, FILM COATED 20 7 71335-0969-7 Sildenafil 4 in 1 BOTTLE TABLET, FILM COATED 4 7 71335-0969-8 Sildenafil 90 in 1 BOTTLE TABLET, FILM COATED 90 7 71335-0969-9 Sildenafil 60 in 1 BOTTLE TABLET, FILM COATED 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0969 SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK] 7 Current NDC, Legacy NDC, 10 package rows 20240518_96ae6733-cef9-46cf-bf4e-5368201943bd.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 · 4 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 71335-0969-0 71335096900 15 TABLET, FILM COATED in 1 BOTTLE (71335-0969-0) 2019-02-07 0000-00-00 No No Current 71335-0969-1 71335096901 10 TABLET, FILM COATED in 1 BOTTLE (71335-0969-1) 2018-10-18 0000-00-00 No No Current 71335-0969-2 71335096902 5 TABLET, FILM COATED in 1 BOTTLE (71335-0969-2) 2018-12-21 0000-00-00 No No Current 71335-0969-3 71335096903 30 TABLET, FILM COATED in 1 BOTTLE (71335-0969-3) 2018-11-05 0000-00-00 No No Current 71335-0969-4 71335096904 2 TABLET, FILM COATED in 1 BOTTLE (71335-0969-4) 2024-05-17 0000-00-00 No No Current 71335-0969-5 71335096905 6 TABLET, FILM COATED in 1 BOTTLE (71335-0969-5) 2024-05-17 0000-00-00 No No Current 71335-0969-6 71335096906 20 TABLET, FILM COATED in 1 BOTTLE (71335-0969-6) 2018-11-28 0000-00-00 No No Current 71335-0969-7 71335096907 4 TABLET, FILM COATED in 1 BOTTLE (71335-0969-7) 2024-05-17 0000-00-00 No No Current 71335-0969-8 71335096908 90 TABLET, FILM COATED in 1 BOTTLE (71335-0969-8) 2024-05-17 0000-00-00 No No Current 71335-0969-9 71335096909 60 TABLET, FILM COATED in 1 BOTTLE (71335-0969-9) 2024-05-17 0000-00-00 No No Current