Sildenafil

Product NDC
71335-1777
11-digit product format
713351777
Labeler code
71335
Product ID
71335-1777_a509bbc3-0f61-4013-8a8f-77bb0cc4a019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077342
Marketing category
ANDA
Marketing start
2017-12-11
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
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
A077342-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09
A077342-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09
A077342-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077342-001AB
A077342-002AB
A077342-003AB

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 06:07:402026-07A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077342-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2016-03-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077342-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2016-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077342-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2016-03-091e350fbaab3a…

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 06:07:402026-07A077342-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077342-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077342-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077342-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077342-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077342-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077342-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077342-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077342-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077342-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077342-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077342-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077342-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077342-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077342-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077342-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077342-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077342-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077342-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077342-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077342-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077342-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077342-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077342-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077342-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077342-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077342-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077342-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077342-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077342-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077342-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077342-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077342-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077342-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077342-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077342-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077342-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077342-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077342-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077342-001AB11e350fbaab3a…

Additional Listing Data#

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

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
f9ab796c-1912-4137-abec-e8336a850a58Available 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
71335-1777-0Sildenafil15 in 1 BOTTLETABLET, FILM COATED15101
71335-1777-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED10101
71335-1777-2Sildenafil5 in 1 BOTTLETABLET, FILM COATED5101
71335-1777-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED30101
71335-1777-4Sildenafil2 in 1 BOTTLETABLET, FILM COATED2101
71335-1777-5Sildenafil6 in 1 BOTTLETABLET, FILM COATED6101
71335-1777-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED20101
71335-1777-7Sildenafil4 in 1 BOTTLETABLET, FILM COATED4101
71335-1777-8Sildenafil90 in 1 BOTTLETABLET, FILM COATED90101
71335-1777-9Sildenafil60 in 1 BOTTLETABLET, FILM COATED60101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1777SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20241121_f9ab796c-1912-4137-abec-e8336a850a58.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 Prepackf9ab796c-1912-4137-abec-e8336a850a582024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077342
application number: ANDA077342
ndc (product): 71335-1777
SildenafilSILDENAFILTeva Pharmaceuticals USA, Inc.5cbac450-f336-45bd-8d10-9ecfd21866eb2024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077342
application number: ANDA077342
SildenafilSILDENAFILProficient Rx LP43a036a4-8a34-4411-ac8e-bf5063d67d482021-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077342
application number: ANDA077342
SildenafilSILDENAFILProficient Rx LP94eb1f59-2a7d-4230-9ae6-69c34d0833262020-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077342
application number: ANDA077342

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf9ab796c-1912-4137-abec-e8336a850a58101
314229sildenafil 100 MG Oral TabletSCDf9ab796c-1912-4137-abec-e8336a850a58101
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf9ab796c-1912-4137-abec-e8336a850a58101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1777-07133517770015 TABLET, FILM COATED in 1 BOTTLE (71335-1777-0) 2024-10-310000-00-00NoNoCurrent
71335-1777-17133517770110 TABLET, FILM COATED in 1 BOTTLE (71335-1777-1) 2021-03-120000-00-00NoNoCurrent
71335-1777-2713351777025 TABLET, FILM COATED in 1 BOTTLE (71335-1777-2) 2021-08-170000-00-00NoNoCurrent
71335-1777-37133517770330 TABLET, FILM COATED in 1 BOTTLE (71335-1777-3) 2021-02-120000-00-00NoNoCurrent
71335-1777-4713351777042 TABLET, FILM COATED in 1 BOTTLE (71335-1777-4) 2024-10-310000-00-00NoNoCurrent
71335-1777-5713351777056 TABLET, FILM COATED in 1 BOTTLE (71335-1777-5) 2024-10-310000-00-00NoNoCurrent
71335-1777-67133517770620 TABLET, FILM COATED in 1 BOTTLE (71335-1777-6) 2021-04-140000-00-00NoNoCurrent
71335-1777-7713351777074 TABLET, FILM COATED in 1 BOTTLE (71335-1777-7) 2024-10-310000-00-00NoNoCurrent
71335-1777-87133517770890 TABLET, FILM COATED in 1 BOTTLE (71335-1777-8) 2021-04-120000-00-00NoNoCurrent
71335-1777-97133517770960 TABLET, FILM COATED in 1 BOTTLE (71335-1777-9) 2024-10-310000-00-00NoNoCurrent