Sildenafil Citrate

Product NDC
59762-0034
11-digit product format
597620034
Labeler code
59762
Product ID
59762-0034_6b8ead94-5df8-4fbd-a75e-388f8147fe5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020895
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-12-01
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020895-001VIAGRASILDENAFIL CITRATEEQ 25MG BASETABLET / ORALABRLD1998-03-27
N020895-002VIAGRASILDENAFIL CITRATEEQ 50MG BASETABLET / ORALABRLD1998-03-27
N020895-003VIAGRASILDENAFIL CITRATEEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020895-001AB
N020895-002AB
N020895-003AB

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 06:07:402026-07N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020895-002VIAGRAEQ 50MG BASETABLET / ORALABRLD1998-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020895-003VIAGRAEQ 100MG BASETABLET / ORALABRLD, RS1998-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020895-001VIAGRAEQ 25MG BASETABLET / ORALABRLD1998-03-271e350fbaab3a…

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 06:07:402026-07N020895-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020895-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020895-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020895-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020895-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020895-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020895-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020895-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020895-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020895-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020895-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020895-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020895-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020895-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020895-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020895-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020895-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020895-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020895-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020895-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020895-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020895-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020895-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020895-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020895-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020895-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020895-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020895-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020895-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020895-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020895-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020895-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020895-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020895-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020895-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020895-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020895-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020895-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020895-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020895-001AB11e350fbaab3a…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020895-00164690122019-10-22U-15574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020895-0016469012*PED2020-04-22Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020895-00264690122019-10-22U-15574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020895-0026469012*PED2020-04-22Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020895-00364690122019-10-22U-15574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020895-0036469012*PED2020-04-22Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020895-0016469012*PED2020-04-22Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020895-0026469012*PED2020-04-22Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020895-0036469012*PED2020-04-22Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020895-0016469012*PED2020-04-22Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020895-0026469012*PED2020-04-22Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020895-0036469012*PED2020-04-22Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N020895-00164690122019-10-22U-1553f01610625f2…
2019-12-14 00:12 UTC2019-12N020895-0016469012*PED2020-04-22Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020895-00264690122019-10-22U-1553f01610625f2…
2019-12-14 00:12 UTC2019-12N020895-0026469012*PED2020-04-22Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020895-00364690122019-10-22U-1553f01610625f2…
2019-12-14 00:12 UTC2019-12N020895-0036469012*PED2020-04-22Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020895-00164690122019-10-22U-155b00525d2431f…
2019-09-15 20:21 UTC2019-09N020895-0016469012*PED2020-04-22Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020895-00264690122019-10-22U-155b00525d2431f…
2019-09-15 20:21 UTC2019-09N020895-0026469012*PED2020-04-22Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020895-00364690122019-10-22U-155b00525d2431f…
2019-09-15 20:21 UTC2019-09N020895-0036469012*PED2020-04-22Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020895-00164690122019-10-22U-155ea99ee380514…
2019-07-19 19:46 UTC2019-07N020895-0016469012*PED2020-04-22Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020895-00264690122019-10-22U-155ea99ee380514…
2019-07-19 19:46 UTC2019-07N020895-0026469012*PED2020-04-22Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020895-00364690122019-10-22U-155ea99ee380514…
2019-07-19 19:46 UTC2019-07N020895-0036469012*PED2020-04-22Pediatric extensionea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE25 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312950Internal RxNorm lookup
314228Internal RxNorm lookup
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
98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0Available 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
59762-0034-1Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0034-1EA - Each59762-00347086bf00-25db-46c1-b21b-05b9387357eb12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0034SILDENAFIL CITRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 1 package rows20250504_98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFIL CITRATEMylan Pharmaceuticals Inc.98a9897b-0cbc-4ea6-9ac2-4dd719a2ede02024-08-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 020895
application number: NDA020895
ndc (product): 59762-0034
ViagraSILDENAFIL CITRATEViatris Specialty LLCd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e2023-11-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 020895
application number: NDA020895
ViagraSILDENAFIL CITRATEPFIZER LABORATORIES DIV PFIZER INC0b0be196-0c62-461c-94f4-9a35339b45012017-12-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020895
application number: NDA020895

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314228sildenafil citrate 25 MG Oral TabletPSN98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
312950sildenafil citrate 50 MG Oral TabletPSN98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314229sildenafil 100 MG Oral TabletSCD98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314228sildenafil 25 MG Oral TabletSCD98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
312950sildenafil 50 MG Oral TabletSCD98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0034-15976200340130 TABLET, FILM COATED in 1 BOTTLE (59762-0034-1) 2017-12-010000-00-00NoNoCurrent