SILDENAFIL

Product NDC
69097-952
11-digit product format
690970952
Labeler code
69097
Product ID
69097-952_31499b53-d7e9-49e4-8eaa-c527c7403f9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET
Route
ORAL
Labeler
CIPLA USA INC.,
Application
ANDA207178
Marketing category
ANDA
Marketing start
2020-07-10
Substance
SILDENAFIL CITRATE
Active strength
50 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69097-952-02fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69097-952-07fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69097-952-0286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69097-952-0786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69097-952-02bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69097-952-07bd6a592717d7…303034d00443…

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
A207178-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02
A207178-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02
A207178-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207178-001AB
A207178-002AB
A207178-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207178-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-03-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207178-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-03-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207178-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2020-03-021e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207178-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207178-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207178-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207178-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207178-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207178-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207178-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207178-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207178-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207178-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207178-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207178-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207178-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207178-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207178-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207178-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207178-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207178-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207178-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207178-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207178-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207178-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207178-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207178-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207178-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207178-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207178-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207178-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207178-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207178-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207178-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207178-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207178-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207178-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207178-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207178-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207178-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207178-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207178-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207178-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 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
15372a7c-2935-48dc-a55a-8966719b50beAvailable 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
69097-952-02SILDENAFIL30 in 1 BOTTLETABLET303
69097-952-07SILDENAFIL100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-952-02EA - Each69097-9524746e815-4f79-46ec-938e-f2113585f62d12020-08-06
69097-952-07EA - Each69097-952d5c021ca-e367-4665-82b3-7ed39ad5637112020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-952SILDENAFIL TABLET [CIPLA USA INC.,]3Current NDC, Legacy NDC, 2 package rows20230504_15372a7c-2935-48dc-a55a-8966719b50be.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILDENAFILSILDENAFILAppco Pharma LLCdf1cc749-caec-4bf0-aa4d-db9dcc5257c32026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207178
application number: ANDA207178
SILDENAFILSILDENAFILAphena Pharma Solutions - Tennessee, LLCcdab7ef5-39cb-45cc-b2bf-5f634f2f54992023-11-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207178
application number: ANDA207178
SILDENAFILSILDENAFILCIPLA USA INC.,15372a7c-2935-48dc-a55a-8966719b50be2023-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207178
application number: ANDA207178
ndc (product): 69097-952
SILDENAFILSILDENAFILExelan Pharmaceuticals, Inc.1883785c-a1a4-48fe-b722-afacf2875ca82022-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207178
application number: ANDA207178
SILDENAFILSILDENAFILProficient Rx LP7086e222-0f2b-4c02-84c0-4f8635c909932021-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207178
application number: ANDA207178

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN15372a7c-2935-48dc-a55a-8966719b50be3
314228sildenafil citrate 25 MG Oral TabletPSN15372a7c-2935-48dc-a55a-8966719b50be3
312950sildenafil citrate 50 MG Oral TabletPSN15372a7c-2935-48dc-a55a-8966719b50be3
314229sildenafil 100 MG Oral TabletSCD15372a7c-2935-48dc-a55a-8966719b50be3
314228sildenafil 25 MG Oral TabletSCD15372a7c-2935-48dc-a55a-8966719b50be3
312950sildenafil 50 MG Oral TabletSCD15372a7c-2935-48dc-a55a-8966719b50be3
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY15372a7c-2935-48dc-a55a-8966719b50be3
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY15372a7c-2935-48dc-a55a-8966719b50be3
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY15372a7c-2935-48dc-a55a-8966719b50be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-952-026909709520230 TABLET in 1 BOTTLE (69097-952-02) 30 tablet2020-07-100000-00-00NoNoCurrent
69097-952-0769097095207100 TABLET in 1 BOTTLE (69097-952-07) 100 tablet2020-07-100000-00-00NoNoCurrent