Sildenafil

Product NDC
27241-124
11-digit product format
272410124
Labeler code
27241
Product ID
27241-124_f5da6ecc-eebe-409e-9251-869a73ef4d4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA 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

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
31c0f8ab-ed2e-4ead-a8c0-4055f6c43783Available 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
27241-124-03Sildenafil90 in 1 BOTTLETABLET9012
27241-124-05Sildenafil500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-124-03EA - Each27241-124222b908b-7487-4926-b58e-b007cbc9bc1f12018-11-06
27241-124-05EA - Each27241-124c0c938ab-f963-44ad-8067-b20fa36cbee812025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-124SILDENAFIL TABLET [AJANTA PHARMA USA INC.]10Current NDC, Legacy NDC, 2 package rows20250306_31c0f8ab-ed2e-4ead-a8c0-4055f6c43783.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
ndc (product): 27241-124
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 TabletPSNfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil 20 MG Oral TabletSCDfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil citrate 20 MG Oral TabletPSN31c0f8ab-ed2e-4ead-a8c0-4055f6c4378312
577033sildenafil 20 MG Oral TabletSCD31c0f8ab-ed2e-4ead-a8c0-4055f6c4378312
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY31c0f8ab-ed2e-4ead-a8c0-4055f6c4378312
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
577033sildenafil citrate 20 MG Oral TabletPSNd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil 20 MG Oral TabletSCDd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil citrate 20 MG Oral TabletPSNd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil 20 MG Oral TabletSCDd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil citrate 20 MG Oral TabletPSNd462e818-af97-0b23-e053-2995a90ace223
577033sildenafil citrate 20 MG Oral TabletPSNd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil citrate 20 MG Oral TabletPSNcc3656ac-3a38-a650-e053-2a95a90a912a3
577033sildenafil 20 MG Oral TabletSCDd462e818-af97-0b23-e053-2995a90ace223
577033sildenafil 20 MG Oral TabletSCDd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG Oral TabletSCDcc3656ac-3a38-a650-e053-2a95a90a912a3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd462e818-af97-0b23-e053-2995a90ace223
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYcc3656ac-3a38-a650-e053-2a95a90a912a3
577033sildenafil citrate 20 MG Oral TabletPSN7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil 20 MG Oral TabletSCD7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil citrate 20 MG Oral TabletPSNefd56b83-79ce-42fa-a690-6bbe5e766d4e1
577033sildenafil 20 MG Oral TabletSCDefd56b83-79ce-42fa-a690-6bbe5e766d4e1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYefd56b83-79ce-42fa-a690-6bbe5e766d4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-124-032724101240390 TABLET in 1 BOTTLE (27241-124-03) 90 tablet2018-05-040000-00-00NoNoCurrent
27241-124-0527241012405500 TABLET in 1 BOTTLE (27241-124-05) 500 tablet2025-08-19NoNoCurrent