Home NDC 59762-0033 Sildenafil
Product NDC 59762-0033
11-digit product format 597620033
Labeler code 59762
Product ID 59762-0033_c1cc0357-ac81-40b6-a401-dfd941495be5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021845
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-09-27
Marketing end 2026-07-31
Substance SILDENAFIL CITRATE
Active strength 20 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
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# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-0033-1 Sildenafil 90 in 1 BOTTLE TABLET, FILM COATED 90 19 59762-0033-3 Sildenafil 300 in 1 BOTTLE TABLET, FILM COATED 300 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SILDENAFIL CITRATE ACTIVE INGREDIENT BW9B0ZE037 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 SILDENAFIL ACTIVE MOIETY 3M7OB98Y7H SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 SILDENAFIL CITRATE ACTIVE INGREDIENT BW9B0ZE037 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 SILDENAFIL ACTIVE MOIETY 3M7OB98Y7H SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC] 9 SILDENAFIL CITRATE ACTIVE INGREDIENT BW9B0ZE037 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 SILDENAFIL ACTIVE MOIETY 3M7OB98Y7H SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-0033 SILDENAFIL TABLET, FILM COATED SILDENAFIL POWDER, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.] 19 Current NDC, Legacy NDC, 2 package rows 20250503_56a962e8-de00-4a97-8904-0b1bd217dd83.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 59762-0033-1 59762003301 90 TABLET, FILM COATED in 1 BOTTLE (59762-0033-1) 2012-09-27 0000-00-00 No No Current 59762-0033-3 59762003303 300 TABLET, FILM COATED in 1 BOTTLE (59762-0033-3) 2020-11-09 2026-07-31 No No Current