Sildenafil

Product NDC
51655-468
11-digit product format
516550468
Labeler code
51655
Product ID
51655-468_490f11b5-2d18-a878-e063-6394a90a8128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA202659
Marketing category
ANDA
Marketing start
2020-11-06
Substance
SILDENAFIL CITRATE
Active strength
100 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202659-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11
A202659-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11
A202659-003SILDENAFIL 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
A202659-001AB
A202659-002AB
A202659-003AB

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 06:07:402026-07A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-111e350fbaab3a…

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 06:07:402026-07A202659-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202659-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202659-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202659-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202659-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE100 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
314229Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3089ee6-190d-4749-e053-2a95a90a15d8Available 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
51655-468-54Sildenafil15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
51655-468-87Sildenafil6 in 1 BOTTLE, PLASTICTABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-468SILDENAFIL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230328_f3089ee6-190d-4749-e053-2a95a90a15d8.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILREMEDYREPACK INC.99bc66a4-05d1-4372-a25a-1153d7af580e2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.e1af7b6a-378e-4337-858f-85a926eec1022026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.4e3034af-bee5-4df4-8beb-fbd2b510ad732026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILBryant Ranch Prepacke22902bd-e5a8-4df6-ae77-8a0a1484cc502026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILCamber Pharmaceuticals, Inc.dc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79982026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILCamber Pharmaceuticals, Inc.96ab1605-e171-4e86-b357-2d9378f7a05a2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNorthwind Health Company, LLCf3089ee6-190d-4749-e053-2a95a90a15d82026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
ndc (product): 51655-468
SildenafilSILDENAFILPreferred Pharmaceuticals, Inc.174ef537-e3e6-42bd-a478-47b930ddc7612025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SILDENAFILSILDENAFILDIRECT RXa84a418a-155c-7be7-e053-2995a90a81582025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILBryant Ranch Prepackf66ce83b-bad6-4180-a8c4-8475a8ec50b72024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.78101030-ef1d-44b9-e053-2991aa0a158d2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.7925711e-2e89-fd93-e053-2991aa0a507f2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.7d68a3d3-590b-0bd9-e053-2a91aa0ae8cd2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILA-S Medication Solutionseaeab74e-38cc-4621-9ce8-8a5d74a29a9e2023-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILA-S Medication Solutions997197bf-7706-4e12-97df-b0a9ea6d3a102023-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILA-S Medication Solutions3145ceda-8c1e-4601-8a9d-5fc4978226d62023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILXLCARE Pharmaceuticals INC.ae732301-384f-43ae-80d1-5e3784fe1dca2023-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILProficient Rx LP0aced3eb-cb0b-4135-905c-b274505aa7402022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILProficient Rx LP5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf3089ee6-190d-4749-e053-2a95a90a15d82
314229sildenafil 100 MG Oral TabletSCDf3089ee6-190d-4749-e053-2a95a90a15d82
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf3089ee6-190d-4749-e053-2a95a90a15d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-468-545165504685415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-468-54) 2020-11-06NoNoCurrent
51655-468-87516550468876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-468-87) 2020-11-06NoNoCurrent