SILDENAFIL CITRATE

Product NDC
50090-3905
11-digit product format
500903905
Labeler code
50090
Product ID
50090-3905_c980e5b1-b4ad-4497-b183-7ec26c897cf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3905-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3905-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3905-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3905-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3905-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3905-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3905-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3905-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3905-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3905-01332a3947898…d4bfe170f9cd…

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
A091479-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091479-001AB

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 06:07:402026-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063f01610625f2…
2019-09-15 20:21 UTC2019-09A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06e64feba35796…

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 06:07:402026-07A091479-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091479-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091479-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091479-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091479-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091479-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091479-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091479-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091479-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091479-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091479-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091479-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091479-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091479-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091479-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091479-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091479-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091479-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091479-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091479-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091479-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091479-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091479-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091479-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091479-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091479-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091479-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091479-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091479-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091479-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091479-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091479-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091479-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091479-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091479-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091479-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091479-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091479-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091479-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091479-001AB1e64feba35796…

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
28a3376b-e50e-4789-9916-803ba29a1522Available 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
50090-3905-0SILDENAFIL CITRATE30 in 1 BOTTLETABLET305
50090-3905-1SILDENAFIL CITRATE90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3905-0EA - Each50090-3905707c8a76-7848-4383-8f34-d127de793b7d12024-12-10
50090-3905-1EA - Each50090-39056f89c404-ce3d-4ab5-a1cf-b8904e8a2b8312024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3905SILDENAFIL CITRATE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20241027_28a3376b-e50e-4789-9916-803ba29a1522.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
SildenafilSILDENAFILBryant Ranch Prepack486dcfc4-f07a-4a78-86f0-f1c5ae448dc12026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFILSILDENAFILMajor Pharmaceuticalsa65b5fb3-ca3c-4226-9caa-42fb9a2f73732026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SildenafilSILDENAFILTorrent Pharmaceuticals Limited1bc081f2-399d-43fa-9e0f-9f8df0118e992026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.48c56418-0e45-083f-e063-6294a90a57b32026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFILSILDENAFILCardinal Health 107, LLCc5ac2265-393a-4fbe-b974-1dd0b9243ec82026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SildenafilSILDENAFILProficient Rx LP71140bd5-0a51-4c01-ad0d-193d08ea67dd2025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFIL CITRATESILDENAFIL CITRATEA-S Medication Solutions28a3376b-e50e-4789-9916-803ba29a15222024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
ndc (product): 50090-3905
Sildenafil CitrateSILDENAFIL CITRATEAdvanced Rx Pharmacy of Tennessee, LLCf925abbe-4977-00b0-e053-6294a90a6e532024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFIL CITRATESILDENAFIL CITRATEAsclemed USA, Inc.49a95b25-08b3-4cfe-a60b-c5132c280be22023-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil 20 MG Oral TabletSCD28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY28a3376b-e50e-4789-9916-803ba29a15225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3905-05009039050030 TABLET in 1 BOTTLE (50090-3905-0) 30 tablet2018-12-050000-00-00NoNoCurrent
50090-3905-15009039050190 TABLET in 1 BOTTLE, PLASTIC (50090-3905-1) 90 tablet2014-11-280000-00-00NoNoCurrent