Sildenafil

Product NDC
68071-2602
11-digit product format
680712602
Labeler code
68071
Product ID
68071-2602_3ab073e6-dfb5-0795-e063-6294a90ab146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210394
Marketing category
ANDA
Marketing start
2018-05-04
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

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2602-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2602-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2602-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2602-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2602-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2602-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2602-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
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
d35f8d6b-e642-78bb-e053-2995a90abb2eAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2602-1Sildenafil10 in 1 BOTTLETABLET103
68071-2602-3Sildenafil30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2602SILDENAFIL TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20230715_d35f8d6b-e642-78bb-e053-2995a90abb2e.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
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
ndc (product): 68071-2602
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 TabletPSNd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG Oral TabletSCDd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd35f8d6b-e642-78bb-e053-2995a90abb2e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2602-16807126020110 TABLET in 1 BOTTLE (68071-2602-1) 10 tablet2025-07-24NoNoCurrent
68071-2602-36807126020330 TABLET in 1 BOTTLE (68071-2602-3) 30 tablet2021-12-170000-00-00NoNoCurrent