Home NDC 58151-395 Revatio
Product NDC 58151-395
11-digit product format 581510395
Labeler code 58151
Product ID 58151-395_3fa2b889-ff04-4db1-b2c8-c0238efe240b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil citrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Viatris Specialty LLC
Application NDA022473
Marketing category NDA
Marketing start 2025-04-09
Substance SILDENAFIL CITRATE
Active strength .8 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022473-001 REVATIO SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022473-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022473-001 M-287 2026-01-31
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 2 · 42 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 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022473-001 REVATIO EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-11-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Revatio
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE .8 mg/mL
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577033 Internal RxNorm lookup 581645 Internal RxNorm lookup 882527 Internal RxNorm lookup 882530 Internal RxNorm lookup 1307427 Internal RxNorm lookup 1307431 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 58151-395-31 Revatio 12.5 mL in 1 VIAL INJECTION, SOLUTION 12.5 4 58151-395-31 Revatio 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-395 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [VIATRIS SPECIALTY LLC] 3 Current NDC, 2 package rows 20250410_3bb9363e-b28d-4019-8aae-539233dca214.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 · 1 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 58151-395-31 58151039531 1 VIAL in 1 CARTON (58151-395-31) / 12.5 mL in 1 VIAL 1 vial 2025-04-09 No No Current