Home NDC 51407-987 Sildenafil
Product NDC 51407-987
11-digit product format 514070987
Labeler code 51407
Product ID 51407-987_512d1e71-2031-ab12-e063-6394a90a80e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA202954
Marketing category ANDA
Marketing start 2025-03-06
Substance SILDENAFIL CITRATE
Active strength 20 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A202954-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2025-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202954-001 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 A202954-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2025-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202954-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2025-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202954-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2025-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202954-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2025-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202954-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2025-03-06 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202954-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2025-03-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sildenafil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 20 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 577033 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 51407-987-90 Sildenafil 90 in 1 BOTTLE TABLET, FILM COATED 90 1
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 Sample Exclude flag Status 51407-987-90 51407098790 90 TABLET, FILM COATED in 1 BOTTLE (51407-987-90) 2026-02-20 No No Current