Sildenafil Citrate

Product NDC
71335-1437
11-digit product format
713351437
Labeler code
71335
Product ID
71335-1437_7d482029-8619-45c8-bf0d-33af01a33d66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206401
Marketing category
ANDA
Marketing start
2018-10-12
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 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
A206401-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-12
A206401-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-12
A206401-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206401-001AB
A206401-002AB
A206401-003AB

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 UTC2026-02A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206401-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-10-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206401-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-10-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206401-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-10-128072bd15b7f6…

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 UTC2026-02A206401-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206401-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206401-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206401-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206401-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206401-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206401-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206401-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206401-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206401-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206401-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206401-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206401-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206401-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206401-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206401-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206401-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206401-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206401-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206401-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206401-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206401-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206401-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206401-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206401-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206401-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206401-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206401-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206401-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206401-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206401-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206401-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206401-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206401-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206401-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206401-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206401-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206401-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206401-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206401-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil Citrate
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
824dcd79-bc82-4b3a-8028-3c1bca1a7a0aAvailable 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
71335-1437-0Sildenafil Citrate15 in 1 BOTTLETABLET, FILM COATED155
71335-1437-1Sildenafil Citrate10 in 1 BOTTLETABLET, FILM COATED105
71335-1437-2Sildenafil Citrate5 in 1 BOTTLETABLET, FILM COATED55
71335-1437-3Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED305
71335-1437-4Sildenafil Citrate2 in 1 BOTTLETABLET, FILM COATED25
71335-1437-5Sildenafil Citrate6 in 1 BOTTLETABLET, FILM COATED65
71335-1437-6Sildenafil Citrate20 in 1 BOTTLETABLET, FILM COATED205
71335-1437-7Sildenafil Citrate4 in 1 BOTTLETABLET, FILM COATED45
71335-1437-8Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED905
71335-1437-9Sildenafil Citrate60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1437SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20240410_824dcd79-bc82-4b3a-8028-3c1bca1a7a0a.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFILBryant Ranch Prepack824dcd79-bc82-4b3a-8028-3c1bca1a7a0a2026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
ndc (product): 71335-1437
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.fbe75c2c-0aff-9ade-e053-6394a90a1ea42026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILQuallent Pharmaceuticals Health LLC41b67fd2-3d9a-49d6-88b8-285044b98dc12025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILAjanta Pharma USA Inc.2ccc6fa6-f8ae-4191-806f-a887244e516a2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILPreferred Pharmaceuticals Inc.878b4c44-cddc-42cb-b9b5-911451ad15302025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.155c7549-b7d6-0c06-e063-6294a90ac65c2025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals, Inc.1d614710-708e-f11c-e063-6394a90a05a52024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFIL CITRATENuCare Pharmaceuticals, Inc.20ead8ca-7cec-2d80-e063-6394a90af5482024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILAdvanced Rx of Tennessee, LLC1ceb575b-2687-0456-e063-6394a90aa88a2024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.1b1ab00d-de9c-4614-e063-6394a90afcde2024-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.0bb3eb8d-05cd-b4cd-e063-6294a90a94bb2024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILA-S Medication Solutionsbf1a22a2-6a69-46c9-933d-e474e88637e92023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILProficient Rx LPb9b1d6ee-da42-4ef2-ab93-cd36d7f341502023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401
Sildenafil CitrateSILDENAFILAsclemed USA, Inc.0500a861-359f-4e12-beb5-0cac8cd6ae1c2023-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206401
application number: ANDA206401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN824dcd79-bc82-4b3a-8028-3c1bca1a7a0a5
314229sildenafil 100 MG Oral TabletSCD824dcd79-bc82-4b3a-8028-3c1bca1a7a0a5
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY824dcd79-bc82-4b3a-8028-3c1bca1a7a0a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1437-07133514370015 TABLET, FILM COATED in 1 BOTTLE (71335-1437-0) 2024-04-030000-00-00NoNoCurrent
71335-1437-17133514370110 TABLET, FILM COATED in 1 BOTTLE (71335-1437-1) 2020-01-090000-00-00NoNoCurrent
71335-1437-2713351437025 TABLET, FILM COATED in 1 BOTTLE (71335-1437-2) 2024-04-030000-00-00NoNoCurrent
71335-1437-37133514370330 TABLET, FILM COATED in 1 BOTTLE (71335-1437-3) 2019-12-110000-00-00NoNoCurrent
71335-1437-4713351437042 TABLET, FILM COATED in 1 BOTTLE (71335-1437-4) 2020-04-270000-00-00NoNoCurrent
71335-1437-5713351437056 TABLET, FILM COATED in 1 BOTTLE (71335-1437-5) 2024-04-030000-00-00NoNoCurrent
71335-1437-67133514370620 TABLET, FILM COATED in 1 BOTTLE (71335-1437-6) 2020-01-020000-00-00NoNoCurrent
71335-1437-7713351437074 TABLET, FILM COATED in 1 BOTTLE (71335-1437-7) 2024-04-030000-00-00NoNoCurrent
71335-1437-87133514370890 TABLET, FILM COATED in 1 BOTTLE (71335-1437-8) 2020-01-080000-00-00NoNoCurrent
71335-1437-97133514370960 TABLET, FILM COATED in 1 BOTTLE (71335-1437-9) 2020-06-040000-00-00NoNoCurrent