Home NDC 82347-0205 Sildenafil
Product NDC 82347-0205
11-digit product format 823470205
Labeler code 82347
Product ID 82347-0205_567bd8f5-2456-8cb2-e063-6394a90ab411
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil citrate
Dosage form FILM
Route ORAL
Labeler Yaral Pharma Inc.
Application NDA210858
Marketing category NDA
Marketing start 2026-02-15
Substance SILDENAFIL CITRATE
Active strength 25 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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210858-001 VYBRIQUE SILDENAFIL CITRATE EQ 25MG BASE FILM / ORAL RLD 2025-12-16 N210858-002 VYBRIQUE SILDENAFIL CITRATE EQ 50MG BASE FILM / ORAL RLD 2025-12-16 N210858-003 VYBRIQUE SILDENAFIL CITRATE EQ 75MG BASE FILM / ORAL RLD 2025-12-16 N210858-004 VYBRIQUE SILDENAFIL CITRATE EQ 100MG BASE FILM / ORAL RLD, RS 2025-12-16
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210858-001 11123287 2033-12-16 Drug product 2026-01-09 N210858-002 11123287 2033-12-16 Drug product 2026-01-09 N210858-003 11123287 2033-12-16 Drug product 2026-01-09 N210858-004 11123287 2033-12-16 Drug product 2026-01-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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.
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 2026-09-14 22:38:34 2026-08 N210858-001 VYBRIQUE EQ 25MG BASE FILM / ORAL RLD 2025-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210858-002 VYBRIQUE EQ 50MG BASE FILM / ORAL RLD 2025-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210858-003 VYBRIQUE EQ 75MG BASE FILM / ORAL RLD 2025-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210858-004 VYBRIQUE EQ 100MG BASE FILM / ORAL RLD, RS 2025-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210858-001 VYBRIQUE EQ 25MG BASE FILM / ORAL RLD 2025-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210858-002 VYBRIQUE EQ 50MG BASE FILM / ORAL RLD 2025-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210858-003 VYBRIQUE EQ 75MG BASE FILM / ORAL RLD 2025-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210858-004 VYBRIQUE EQ 100MG BASE FILM / ORAL RLD, RS 2025-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210858-001 VYBRIQUE EQ 25MG BASE FILM / ORAL RLD 2025-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210858-002 VYBRIQUE EQ 50MG BASE FILM / ORAL RLD 2025-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210858-003 VYBRIQUE EQ 75MG BASE FILM / ORAL RLD 2025-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210858-004 VYBRIQUE EQ 100MG BASE FILM / ORAL RLD, RS 2025-12-16 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-001 VYBRIQUE EQ 25MG BASE FILM / ORAL RLD 2025-12-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-002 VYBRIQUE EQ 50MG BASE FILM / ORAL RLD 2025-12-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-003 VYBRIQUE EQ 75MG BASE FILM / ORAL RLD 2025-12-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-004 VYBRIQUE EQ 100MG BASE FILM / ORAL RLD, RS 2025-12-16 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N210858-001 11123287 2033-12-16 Drug product 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210858-002 11123287 2033-12-16 Drug product 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210858-003 11123287 2033-12-16 Drug product 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210858-004 11123287 2033-12-16 Drug product 2026-01-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210858-001 11123287 2033-12-16 Drug product 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210858-002 11123287 2033-12-16 Drug product 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210858-003 11123287 2033-12-16 Drug product 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210858-004 11123287 2033-12-16 Drug product 2026-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210858-001 11123287 2033-12-16 Drug product 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210858-002 11123287 2033-12-16 Drug product 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210858-003 11123287 2033-12-16 Drug product 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210858-004 11123287 2033-12-16 Drug product 2026-01-09 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-001 11123287 2033-12-16 Drug product 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-002 11123287 2033-12-16 Drug product 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-003 11123287 2033-12-16 Drug product 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210858-004 11123287 2033-12-16 Drug product 2026-01-09 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sildenafil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 25 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2735815 Internal RxNorm lookup 2735822 Internal RxNorm lookup 2735825 Internal RxNorm lookup 2735829 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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 Units Marketing start Sample Exclude flag Status 82347-0205-4 82347020504 1 FILM in 1 POUCH (82347-0205-4) 1 film 2026-02-15 No No Current 82347-0205-5 82347020505 4 POUCH in 1 CARTON (82347-0205-5) / 1 FILM in 1 POUCH 4 pouch 2026-02-15 No No Current 82347-0205-6 82347020506 8 POUCH in 1 CARTON (82347-0205-6) / 1 FILM in 1 POUCH 8 pouch 2026-02-15 No No Current