Home NDC 0069-4190 Revatio
Product NDC 0069-4190
11-digit product format 000694190
Labeler code 0069
Product ID 0069-4190_92557457-d941-4560-bfb1-1284d8902907
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PFIZER LABORATORIES DIV PFIZER INC
Application NDA021845
Marketing category NDA
Marketing start 2005-06-03
Marketing end 2029-04-30
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 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 N021845-001 REVATIO SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021845-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N021845-001 M-287 2026-01-31 N021845-001 ODE-469 2030-01-31
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 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021845-001 REVATIO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2005-06-03 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 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 · 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 0069-4190-68 Revatio 90 in 1 BOTTLE TABLET, FILM COATED 90 45
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SILDENAFIL CITRATE ACTIVE INGREDIENT BW9B0ZE037 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 SILDENAFIL ACTIVE MOIETY 3M7OB98Y7H REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 SORBITOL INACTIVE INGREDIENT 506T60A25R REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 WATER INACTIVE INGREDIENT 059QF0KO0R REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 33
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-4190 REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] 44 Current NDC, Legacy NDC, 1 package rows 20250410_f158fe10-d5dc-4432-b2c9-fc665401291b.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 · 2 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 0069-4190-68 00069419068 90 TABLET, FILM COATED in 1 BOTTLE (0069-4190-68) 2005-06-03 0000-00-00 No No Current