Sildenafil

Product NDC
70518-3433
11-digit product format
705183433
Labeler code
70518
Product ID
70518-3433_485bc9db-8666-9f5a-e063-6394a90a7921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210394
Marketing category
ANDA
Marketing start
2022-06-09
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-343370518-3433-0DDiscontinued by firm2026-08-17
excluded packagepackage70518-343370518-3433-3DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-3433-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-3433-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-3433-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-3433-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-3433-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170518-3433-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-3433-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870518-3433-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-3433-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170518-3433-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-3433-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070518-3433-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-3433-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170518-3433-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-3433-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-3433-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-3433-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-3433-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-3433-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870518-3433-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-3433-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-3433-0557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210394-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210394-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210394-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2018-05-04e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210394-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210394-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210394-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210394-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210394-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210394-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210394-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210394-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210394-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210394-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210394-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210394-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210394-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210394-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210394-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210394-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210394-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210394-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210394-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210394-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210394-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210394-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210394-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210394-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210394-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210394-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210394-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210394-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210394-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210394-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210394-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210394-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210394-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210394-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210394-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210394-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210394-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210394-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210394-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210394-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2027-12-31

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
e4f41e9e-d508-4f91-8677-8a19b07139deAvailable 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
70518-3433-0Sildenafil30 in 1 BOXTABLET3010
70518-3433-1Sildenafil1 in 1 POUCHTABLET110
70518-3433-2Sildenafil360 in 1 BOXTABLET36010
70518-3433-3Sildenafil90 in 1 BOXTABLET9010
70518-3433-4Sildenafil180 in 1 BOXTABLET18010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3433SILDENAFIL TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20250112_e4f41e9e-d508-4f91-8677-8a19b07139de.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILREMEDYREPACK INC.e4f41e9e-d508-4f91-8677-8a19b07139de2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
ndc (product): 70518-3433
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.cc3656ac-3a38-a650-e053-2a95a90a912a2026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
SildenafilSILDENAFILQuallent Pharmaceuticals Health LLC333ca682-931f-4edb-95d6-2edbd87631cf2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
SildenafilSILDENAFILAjanta Pharma USA Inc.31c0f8ab-ed2e-4ead-a8c0-4055f6c437832025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
SildenafilSILDENAFILProficient Rx LP7dd302cd-b84d-4d7d-bd1e-2916febbaea52025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.d35f8d6b-e642-78bb-e053-2995a90abb2e2025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
SILDENAFILSILDENAFILDirectRxd1ee9139-13ac-7d5b-e053-2995a90a8e502025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
SildenafilSILDENAFILPreferred Pharmaceuticals Inc.d887377e-90c5-44dc-8455-b23a6755b36f2025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394
SildenafilSILDENAFILBryant Ranch Prepackfe848310-57d8-4492-829c-3e2535754a552024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210394
application number: ANDA210394

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNe4f41e9e-d508-4f91-8677-8a19b07139de10
577033sildenafil 20 MG Oral TabletSCDe4f41e9e-d508-4f91-8677-8a19b07139de10
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYe4f41e9e-d508-4f91-8677-8a19b07139de10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3433-07051834330030 POUCH in 1 BOX (70518-3433-0) / 1 TABLET in 1 POUCH (70518-3433-1) 30 pouch2022-06-090000-00-00NoNoCurrent
70518-3433-1705183433011 in 1 POUCHHistorical
70518-3433-270518343302360 POUCH in 1 BOX (70518-3433-2) / 1 TABLET in 1 POUCH (70518-3433-1) 360 pouch2022-06-090000-00-00NoNoCurrent
70518-3433-37051834330390 in 1 BOXHistorical
70518-3433-470518343304180 POUCH in 1 BOX (70518-3433-4) / 1 TABLET in 1 POUCH (70518-3433-1) 180 pouch2024-01-10NoNoCurrent
70518-3433-570518343305100 POUCH in 1 BOX (70518-3433-5) / 1 TABLET in 1 POUCH (70518-3433-1)100 pouch2026-07-080Current
70518-3433-67051834330650 POUCH in 1 BOX (70518-3433-6) / 1 TABLET in 1 POUCH (70518-3433-1)50 pouch2026-07-080Current