SILDENAFIL CITRATE

Product NDC
71205-657
11-digit product format
712050657
Labeler code
71205
Product ID
71205-657_fd8ab326-7f1b-42b4-a20c-39ed68e79378
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209302
Marketing category
ANDA
Marketing start
2020-09-04
Substance
SILDENAFIL CITRATE
Active strength
100 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209302-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-08-25
A209302-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-08-25
A209302-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2021-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209302-001AB
A209302-002AB
A209302-003AB

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 3 · 110 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2021-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2021-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2021-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALBX2020-08-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALBX2020-08-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALBX2021-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-08-251e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209302-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209302-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209302-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209302-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209302-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209302-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209302-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209302-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209302-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209302-001BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209302-002BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209302-003BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209302-001BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209302-002BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209302-003BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209302-001BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209302-002BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209302-003BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209302-001BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209302-002BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209302-003BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209302-001BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209302-002BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209302-003BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209302-001BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209302-002BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209302-003BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209302-001BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209302-002BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209302-003BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209302-001BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209302-002BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209302-003BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209302-001BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209302-002BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209302-003BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209302-001BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209302-002BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209302-003BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209302-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
SILDENAFIL CITRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE100 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
314229Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30ce6e7f-716e-4a68-a4fb-2bb2d34ed052Available 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
71205-657-02SILDENAFIL CITRATE2 in 1 BOTTLETABLET27
71205-657-10SILDENAFIL CITRATE10 in 1 BOTTLETABLET107
71205-657-11SILDENAFIL CITRATE1000 in 1 BOTTLETABLET10007
71205-657-20SILDENAFIL CITRATE20 in 1 BOTTLETABLET207
71205-657-30SILDENAFIL CITRATE30 in 1 BOTTLETABLET307
71205-657-60SILDENAFIL CITRATE60 in 1 BOTTLETABLET607
71205-657-90SILDENAFIL CITRATE90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-657-02EA - Each71205-657abebfd56-f531-4217-89f8-fb2e3173577712023-08-08
71205-657-10EA - Each71205-6572c91810a-d9b2-484b-845e-d510d5a4f8a112023-08-08
71205-657-11EA - Each71205-65733b7b171-889c-494f-9ee4-29d15b796cdb12025-12-16
71205-657-20EA - Each71205-657a3477f8f-b7d9-459a-94ed-7d2a6e2d328e12023-06-06
71205-657-30EA - Each71205-6579a28f28f-4e01-444a-9ff2-36ed1dbe74ee12022-08-04
71205-657-90EA - Each71205-657781a8367-2378-45f1-9261-42ccb8dda7f812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-657SILDENAFIL CITRATE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20230711_30ce6e7f-716e-4a68-a4fb-2bb2d34ed052.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.f1122baa-8dee-43fc-bd3d-501a55b696b32026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEUmedica Laboratories USA Inc.90477a51-63ba-43f4-a74b-4659a946093c2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATENIVAGEN PHARMACEUTICALS, INC.5ac95dd0-57e4-495c-bf8d-b2e5bbe33e202026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATENorthstar Rx LLC8127ff38-2761-49ec-8ce7-7f971f521cfb2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP8780c159-8b61-402b-afbe-64f5c85d38862025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP30ce6e7f-716e-4a68-a4fb-2bb2d34ed0522025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
ndc (product): 71205-657
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP1add0cab-8873-4cd1-ab53-e05c4ac458b12025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.dc4430cc-8238-4d6d-99ff-bbb9d0b51bd12025-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEAdvanced Rx of Tennessee, LLC30cb7d6a-ce40-c794-e063-6294a90a68612025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEPreferred Pharmaceuticals Inc.5846bff2-6a93-46a7-a547-04459c5908142025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEA-S Medication Solutions6d79946b-72a9-4d1b-a84b-9d1a679a82e22024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP59b623bc-fbdd-4f32-8327-0d600763f4292022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN30ce6e7f-716e-4a68-a4fb-2bb2d34ed0527
314229sildenafil 100 MG Oral TabletSCD30ce6e7f-716e-4a68-a4fb-2bb2d34ed0527
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY30ce6e7f-716e-4a68-a4fb-2bb2d34ed0527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-657-02712050657022 TABLET in 1 BOTTLE (71205-657-02) 2 tablet2023-07-06NoNoCurrent
71205-657-107120506571010 TABLET in 1 BOTTLE (71205-657-10) 10 tablet2022-06-100000-00-00NoNoCurrent
71205-657-11712050657111000 TABLET in 1 BOTTLE (71205-657-11) 1000 tablet2025-10-30NoNoCurrent
71205-657-207120506572020 TABLET in 1 BOTTLE (71205-657-20) 20 tablet2023-01-31NoNoCurrent
71205-657-307120506573030 TABLET in 1 BOTTLE (71205-657-30) 30 tablet2022-05-050000-00-00NoNoCurrent
71205-657-607120506576060 TABLET in 1 BOTTLE (71205-657-60) 60 tablet2022-05-050000-00-00NoNoCurrent
71205-657-907120506579090 TABLET in 1 BOTTLE (71205-657-90) 90 tablet2022-05-050000-00-00NoNoCurrent