Home NDC 0093-5342 Sildenafil
Product NDC 0093-5342
11-digit product format 000935342
Labeler code 0093
Product ID 0093-5342_f85e5bfc-be48-4675-8867-1585f412ccb6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA077342
Marketing category ANDA
Marketing start 2017-12-11
Substance SILDENAFIL CITRATE
Active strength 50 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077342-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 A077342-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 A077342-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09
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 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077342-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2016-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077342-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2016-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077342-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2016-03-09 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 50 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-5342-01 Sildenafil 100 in 1 BOTTLE TABLET, FILM COATED 100 8 0093-5342-56 Sildenafil 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-5342 SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241025_5cbac450-f336-45bd-8d10-9ecfd21866eb.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 0093-5342-01 00093534201 100 TABLET, FILM COATED in 1 BOTTLE (0093-5342-01) 2017-12-11 0000-00-00 No No Current 0093-5342-56 00093534256 30 TABLET, FILM COATED in 1 BOTTLE (0093-5342-56) 2017-12-11 0000-00-00 No No Current