Sildenafil

Product NDC
65862-691
11-digit product format
658620691
Labeler code
65862
Product ID
65862-691_98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-06-11
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
A203962-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11
A203962-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11
A203962-003SILDENAFIL 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
A203962-001AB
A203962-002AB
A203962-003AB

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 06:07:402026-07A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203962-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203962-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203962-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203962-001SILDENAFIL 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 06:07:402026-07A203962-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203962-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203962-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203962-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203962-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203962-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203962-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203962-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203962-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203962-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203962-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203962-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203962-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203962-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203962-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203962-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203962-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203962-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203962-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203962-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203962-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203962-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203962-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203962-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203962-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203962-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203962-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203962-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203962-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203962-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203962-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203962-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203962-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203962-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203962-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203962-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203962-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203962-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203962-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203962-001AB11e350fbaab3a…

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 · 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
363c1e77-e482-47b2-aa1e-851abd770aebAvailable 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
65862-691-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1006
65862-691-05Sildenafil500 in 1 BOTTLETABLET, FILM COATED5006
65862-691-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-691-01EA - Each65862-69161388779-0c8e-4149-9818-e429f52f72a412018-07-03
65862-691-05EA - Each65862-691093f4987-d5e7-4683-939e-dd5f0d6e06d812024-08-12
65862-691-30EA - Each65862-691a0eadcd1-66b2-4601-82ac-122b06ea787e12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-691SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20240618_363c1e77-e482-47b2-aa1e-851abd770aeb.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILA-S Medication Solutionsa10b7ec1-bb59-4906-b32d-fbd2a17ed7a82026-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962
SildenafilSILDENAFILA-S Medication Solutions18bd4315-2446-415b-a6a3-991ba00357682026-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.2916e6c4-bc68-c4d6-e063-6394a90aba792025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.41b2c017-53a0-c687-e063-6394a90a15b22025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.3314d14e-99eb-39e5-e063-6394a90aed942025-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.28f2af84-f4d4-acfe-e063-6294a90ae1282024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962
SildenafilSILDENAFILAurobindo Pharma Limited363c1e77-e482-47b2-aa1e-851abd770aeb2024-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962
ndc (product): 65862-691
SildenafilSILDENAFILProficient Rx LP61c3866e-401d-48b3-a0d2-1e24a33ab5122019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203962
application number: ANDA203962

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil citrate 25 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil citrate 50 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil 100 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil 25 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil 50 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil citrate 100 MG Oral TabletPSN0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil citrate 100 MG Oral TabletPSN61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil 100 MG Oral TabletSCD0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil 100 MG Oral TabletSCD61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil citrate 100 MG Oral TabletPSN3314d14e-99eb-39e5-e063-6394a90aed941
314229sildenafil citrate 100 MG Oral TabletPSN18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil citrate 100 MG Oral TabletPSN41b2c017-53a0-c687-e063-6394a90a15b21
314229sildenafil 100 MG Oral TabletSCD3314d14e-99eb-39e5-e063-6394a90aed941
314229sildenafil 100 MG Oral TabletSCD18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil 100 MG Oral TabletSCD41b2c017-53a0-c687-e063-6394a90a15b21
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY3314d14e-99eb-39e5-e063-6394a90aed941
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY41b2c017-53a0-c687-e063-6394a90a15b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-691-0165862069101100 TABLET, FILM COATED in 1 BOTTLE (65862-691-01) 2018-06-110000-00-00NoNoCurrent
65862-691-0565862069105500 TABLET, FILM COATED in 1 BOTTLE (65862-691-05) 2018-06-110000-00-00NoNoCurrent
65862-691-306586206913030 TABLET, FILM COATED in 1 BOTTLE (65862-691-30) 2018-06-110000-00-00NoNoCurrent