Sildenafil Citrate

Product NDC
50090-3495
11-digit product format
500903495
Labeler code
50090
Product ID
50090-3495_cb1243ed-e267-4b82-b2fa-3d53c4f281fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091448
Marketing category
ANDA
Marketing start
2017-12-11
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 productproduct50090-3495DDiscontinued by firm2026-08-11
excluded packagepackage50090-349550090-3495-0DDiscontinued by firm2026-08-11

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3495-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3495-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3495-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3495-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3495-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3495-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3495-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3495-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3495-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3495-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3495-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3495-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-3495-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-3495-0IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091448-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11
A091448-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11
A091448-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091448-001AB
A091448-002AB
A091448-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091448-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091448-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091448-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091448-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFILProficient Rx LP3522bdcc-8113-4562-8ca1-f3eb884beaea2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ace2bb56-4992-49fe-9311-535b12eea9b42026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.78c4551c-b922-43c9-9a5a-66377ea07bc22026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILRedpharm Drug52614168-3a9e-335d-e063-6394a90ac27f2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILNuCare Pharmaceuticals, Inc.36da8e3a-d17c-e42f-e063-6394a90a1ece2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILPreferred Pharmaceuticals Inc.5f9ff0bb-5634-437a-96eb-249b910c7e812026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepacka05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d62026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepackedb0919d-cbf1-4968-b0eb-342aa811c2ce2026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals Limitedb48630b1-5208-4d00-b56f-21701f2237582026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILNorthwind Health Company, LLCd9de0817-cac1-4ee5-e053-2a95a90a5fa72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448