Sildenafil

Product NDC
71209-107
Requested package NDC
71209-107-11
11-digit product format
712090107
Labeler code
71209
Product ID
71209-107_eff134c4-3240-4132-b9ea-118ce1fa719a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA218045
Marketing category
ANDA
Marketing start
2023-12-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218045-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28
A218045-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-28
A218045-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218045-001AB
A218045-002AB
A218045-003AB

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 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-2884e616aacf4f…
2026-09-14 22:38:342026-08A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-2884e616aacf4f…
2026-09-14 22:38:342026-08A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-2884e616aacf4f…
2026-08-18 06:07:402026-07A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218045-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2023-11-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218045-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2023-11-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218045-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2023-11-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218045-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218045-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218045-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A218045-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218045-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218045-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218045-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218045-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218045-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218045-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218045-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218045-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218045-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218045-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218045-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218045-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218045-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218045-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218045-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218045-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218045-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218045-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218045-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218045-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218045-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218045-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218045-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218045-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218045-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218045-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218045-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218045-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218045-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218045-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218045-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218045-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218045-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218045-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218045-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218045-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c079fc41-7b9a-499d-88ea-86ccb65c828dAvailable 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
71209-107-01Sildenafil30 in 1 BOTTLETABLET, FILM COATED304
71209-107-05Sildenafil100 in 1 BOTTLETABLET, FILM COATED1004
71209-107-11Sildenafil1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-107SILDENAFIL TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED]4Current NDC, 3 package rows20250214_c079fc41-7b9a-499d-88ea-86ccb65c828d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILModavar Pharmaceuticals LLC8c4f22c8-3607-4d64-8821-dd3202f8fa0a2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218045
application number: ANDA218045
SildenafilSILDENAFILCadila Pharmaceuticals Limitedc079fc41-7b9a-499d-88ea-86ccb65c828d2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218045
application number: ANDA218045
ndc (package): 71209-107-11
ndc (product): 71209-107
ndc11 (package): 71209010711

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNc079fc41-7b9a-499d-88ea-86ccb65c828d4
314228sildenafil citrate 25 MG Oral TabletPSNc079fc41-7b9a-499d-88ea-86ccb65c828d4
312950sildenafil citrate 50 MG Oral TabletPSNc079fc41-7b9a-499d-88ea-86ccb65c828d4
314229sildenafil 100 MG Oral TabletSCDc079fc41-7b9a-499d-88ea-86ccb65c828d4
314228sildenafil 25 MG Oral TabletSCDc079fc41-7b9a-499d-88ea-86ccb65c828d4
312950sildenafil 50 MG Oral TabletSCDc079fc41-7b9a-499d-88ea-86ccb65c828d4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYc079fc41-7b9a-499d-88ea-86ccb65c828d4
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYc079fc41-7b9a-499d-88ea-86ccb65c828d4
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYc079fc41-7b9a-499d-88ea-86ccb65c828d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71209-107-11712090107111000 TABLET, FILM COATED in 1 BOTTLE (71209-107-11) 2023-12-01NoNoCurrent