Home NDC 71205-473 SILDENAFIL
Product NDC 71205-473
11-digit product format 712050473
Labeler code 71205
Product ID 71205-473_1d2a3b34-3e71-4a4b-81ed-4ff35976abc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SILDENAFIL
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA207178
Marketing category ANDA
Marketing start 2020-07-10
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 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 A207178-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 A207178-002 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 A207178-003 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02
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 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207178-002 SILDENAFIL CITRATE EQ 50MG BASE TABLET / ORAL AB 2020-03-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207178-003 SILDENAFIL CITRATE EQ 100MG BASE TABLET / ORAL AB 2020-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207178-001 SILDENAFIL CITRATE EQ 25MG BASE TABLET / ORAL AB 2020-03-02 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 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# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-473 SILDENAFIL TABLET [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 5 package rows 20210330_7086e222-0f2b-4c02-84c0-4f8635c90993.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SILDENAFIL SILDENAFIL Appco Pharma LLC df1cc749-caec-4bf0-aa4d-db9dcc5257c3 2026-02-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207178 application number: ANDA207178 SILDENAFIL SILDENAFIL Aphena Pharma Solutions - Tennessee, LLC cdab7ef5-39cb-45cc-b2bf-5f634f2f5499 2023-11-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207178 application number: ANDA207178 SILDENAFIL SILDENAFIL CIPLA USA INC., 15372a7c-2935-48dc-a55a-8966719b50be 2023-05-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207178 application number: ANDA207178 SILDENAFIL SILDENAFIL Exelan Pharmaceuticals, Inc. 1883785c-a1a4-48fe-b722-afacf2875ca8 2022-08-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207178 application number: ANDA207178 SILDENAFIL SILDENAFIL Proficient Rx LP 7086e222-0f2b-4c02-84c0-4f8635c90993 2021-03-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207178 application number: ANDA207178 ndc (product): 71205-473
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 71205-473-10 71205047310 10 TABLET in 1 BOTTLE (71205-473-10) 10 tablet 2020-08-24 0000-00-00 No No Current 71205-473-20 71205047320 20 TABLET in 1 BOTTLE (71205-473-20) 20 tablet 2021-03-23 0000-00-00 No No Current 71205-473-30 71205047330 30 TABLET in 1 BOTTLE (71205-473-30) 30 tablet 2020-08-24 0000-00-00 No No Current 71205-473-60 71205047360 60 TABLET in 1 BOTTLE (71205-473-60) 60 tablet 2020-08-24 0000-00-00 No No Current 71205-473-90 71205047390 90 TABLET in 1 BOTTLE (71205-473-90) 90 tablet 2020-08-24 0000-00-00 No No Current