Home NDC 65862-688 Sildenafil
Product NDC 65862-688
11-digit product format 658620688
Labeler code 65862
Product ID 65862-688_aee36818-4865-49b7-9f54-29c62f8d4fda
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA203963
Marketing category ANDA
Marketing start 2015-11-18
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 A203963-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203963-001 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.
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 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203963-001 SILDENAFIL CITRATE EQ 20MG BASE TABLET / ORAL AB 2015-11-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 65862-688-90 Sildenafil 90 in 1 BOTTLE TABLET, FILM COATED 90 13 65862-688-99 Sildenafil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SILDENAFIL CITRATE ACTIVE INGREDIENT BW9B0ZE037 SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 SILDENAFIL ACTIVE MOIETY 3M7OB98Y7H SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-688 SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 12 Current NDC, Legacy NDC, 2 package rows 20250216_17621e92-79a0-46aa-86c7-ea179e81928d.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 65862-688-90 65862068890 90 TABLET, FILM COATED in 1 BOTTLE (65862-688-90) 2015-11-18 0000-00-00 No No Current 65862-688-99 65862068899 1000 TABLET, FILM COATED in 1 BOTTLE (65862-688-99) 2015-11-18 0000-00-00 No No Current