Sildenafil

Product NDC
50090-4644
11-digit product format
500904644
Labeler code
50090
Product ID
50090-4644_cfb38b4a-1bad-471b-9005-b0cb2a8ff986
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202023
Marketing category
ANDA
Marketing start
2018-06-28
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
25 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct50090-4644IInactivated by FDA2026-08-17
excluded packagepackage50090-464450090-4644-0IInactivated by FDA2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4644-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4644-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4644-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4644-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4644-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4644-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4644-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4644-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4644-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4644-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4644-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4644-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4644-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4644-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4644-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202023-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27
A202023-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27
A202023-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202023-001AB
A202023-002AB
A202023-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202023-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202023-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202023-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-271e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202023-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202023-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202023-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202023-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202023-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202023-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202023-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202023-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202023-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202023-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202023-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202023-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202023-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202023-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202023-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202023-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202023-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202023-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202023-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202023-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202023-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202023-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202023-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202023-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202023-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202023-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202023-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202023-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202023-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202023-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202023-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202023-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202023-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202023-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202023-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202023-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202023-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202023-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202023-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202023-001AB11e350fbaab3a…

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
50090-4644-0Sildenafil10 in 1 BOTTLETABLET, FILM COATED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4644-0EA - Each50090-4644fff8f35c-bc8f-446a-b8b3-58b039a2116512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4644SILDENAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210417_3095b2c2-d0f8-485a-aeda-ef950868c154.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILBryant Ranch Prepackdfe4f616-b5de-458c-a97b-ab860e32320c2026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202023
application number: ANDA202023
SildenafilSILDENAFILAmneal Pharmaceuticals NY LLCa1c3a2a2-8cf5-41c3-9c86-54290570d9162026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202023
application number: ANDA202023
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.f98d51a5-e3c8-2b6c-e053-6294a90ac1462025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202023
application number: ANDA202023
SildenafilSILDENAFILBryant Ranch Prepack96ae6733-cef9-46cf-bf4e-5368201943bd2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202023
application number: ANDA202023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314228sildenafil citrate 25 MG Oral TabletPSN3095b2c2-d0f8-485a-aeda-ef950868c1545
314228sildenafil 25 MG Oral TabletSCD3095b2c2-d0f8-485a-aeda-ef950868c1545
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY3095b2c2-d0f8-485a-aeda-ef950868c1545

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4644-05009046440010 TABLET, FILM COATED in 1 BOTTLE (50090-4644-0) 2019-10-240000-00-00NoNoCurrent