Sildenafil Citrate

Product NDC
52817-295
11-digit product format
528170295
Labeler code
52817
Product ID
52817-295_a8abd38f-2334-34e3-e053-2a95a90acb7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA204883
Marketing category
ANDA
Marketing start
2016-08-01
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204883-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204883-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-203f01610625f2…
2019-09-15 20:21 UTC2019-09A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204883-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2016-06-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204883-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204883-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204883-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204883-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204883-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204883-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204883-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204883-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204883-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204883-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204883-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204883-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204883-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204883-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204883-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204883-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204883-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204883-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204883-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204883-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204883-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204883-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204883-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204883-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204883-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204883-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204883-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204883-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204883-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204883-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204883-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204883-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204883-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204883-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204883-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204883-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204883-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204883-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204883-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204883-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BW9B0ZE037Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577033Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8864c64-22ad-402b-a1e8-cfb53fa02e80Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-295-00Sildenafil Citrate1000 in 1 BOTTLETABLET, FILM COATED10006
52817-295-90Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-295-00EA - Each52817-295a47308e2-77b4-4975-9304-8ce20f48558d12019-06-19
52817-295-90EA - Each52817-2958d78ef7c-81a9-46c2-951e-a6782e9dd1b412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-295SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [TRUPHARMA LLC]6Current NDC, Legacy NDC, 2 package rows20200623_c8864c64-22ad-402b-a1e8-cfb53fa02e80.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFILNorthwind Health Company, LLC471b8574-cb2a-1670-e063-6394a90a2a842026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204883
application number: ANDA204883
Sildenafil CitrateSILDENAFILAdvagen Pharma Ltdce683bbc-a1d2-4f23-b3d1-d9333d91dc552026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204883
application number: ANDA204883
Sildenafil CitrateSILDENAFILNorthwind Health Company, LLCd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204883
application number: ANDA204883
Sildenafil CitrateSILDENAFILProficient Rx LP88825206-1b91-4d95-876c-71100912d3782024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204883
application number: ANDA204883
Sildenafil CitrateSILDENAFILTruPharma LLCc8864c64-22ad-402b-a1e8-cfb53fa02e802020-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204883
application number: ANDA204883
ndc (product): 52817-295
Sildenafil CitrateSILDENAFILProficient Rx LP9ebc1a11-3f4b-4eb3-89f5-f430a330887d2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204883
application number: ANDA204883

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNc8864c64-22ad-402b-a1e8-cfb53fa02e806
577033sildenafil 20 MG Oral TabletSCDc8864c64-22ad-402b-a1e8-cfb53fa02e806
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYc8864c64-22ad-402b-a1e8-cfb53fa02e806
577033sildenafil citrate 20 MG Oral TabletPSN479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil 20 MG Oral TabletSCD479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil citrate 20 MG Oral TabletPSNd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil citrate 20 MG Oral TabletPSNf4c26992-c9bb-e20f-e053-2a95a90afb652
577033sildenafil citrate 20 MG Oral TabletPSNf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil citrate 20 MG Oral TabletPSN9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG Oral TabletSCDd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil 20 MG Oral TabletSCDf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil 20 MG Oral TabletSCD9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG Oral TabletSCDf4c26992-c9bb-e20f-e053-2a95a90afb652
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf4c26992-c9bb-e20f-e053-2a95a90afb652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-295-00528170295001000 TABLET, FILM COATED in 1 BOTTLE (52817-295-00) 2016-08-010000-00-00NoNoCurrent
52817-295-905281702959090 TABLET, FILM COATED in 1 BOTTLE (52817-295-90) 2016-08-010000-00-00NoNoCurrent