SILDENAFIL CITRATE

Product NDC
13668-187
11-digit product format
136680187
Labeler code
13668
Product ID
13668-187_e835d1de-642e-4ea7-98ff-390effd8331f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091448
Marketing category
ANDA
Marketing start
2018-06-11
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
2027-12-31
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
A091448-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11
A091448-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11
A091448-003SILDENAFIL 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
A091448-001AB
A091448-002AB
A091448-003AB

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 UTC2026-02A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091448-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-118072bd15b7f6…

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 UTC2026-02A091448-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091448-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091448-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091448-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091448-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091448-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091448-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091448-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091448-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091448-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091448-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091448-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091448-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091448-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091448-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091448-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091448-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
SILDENAFIL CITRATE
Listing expiration
2027-12-31

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
b48630b1-5208-4d00-b56f-21701f223758Available 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
13668-187-01SILDENAFIL CITRATE100 in 1 BOTTLETABLET, FILM COATED10015
13668-187-05SILDENAFIL CITRATE500 in 1 BOTTLETABLET, FILM COATED50015
13668-187-10SILDENAFIL CITRATE1000 in 1 BOTTLETABLET, FILM COATED100015
13668-187-18SILDENAFIL CITRATE1800 in 1 BOTTLETABLET, FILM COATED180015
13668-187-30SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-187-01EA - Each13668-187a47f0a14-7544-489b-9436-6cfc5dea605712018-07-03
13668-187-30EA - Each13668-1873cb8c6bb-2a42-46a8-8114-4f68ccdb281412018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-187SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]14Current NDC, Legacy NDC, 5 package rows20241210_b48630b1-5208-4d00-b56f-21701f223758.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFILProficient Rx LP3522bdcc-8113-4562-8ca1-f3eb884beaea2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ace2bb56-4992-49fe-9311-535b12eea9b42026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.78c4551c-b922-43c9-9a5a-66377ea07bc22026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILRedpharm Drug52614168-3a9e-335d-e063-6394a90ac27f2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILNuCare Pharmaceuticals, Inc.36da8e3a-d17c-e42f-e063-6394a90a1ece2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILPreferred Pharmaceuticals Inc.5f9ff0bb-5634-437a-96eb-249b910c7e812026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepacka05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d62026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepackedb0919d-cbf1-4968-b0eb-342aa811c2ce2026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals Limitedb48630b1-5208-4d00-b56f-21701f2237582026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448
ndc (product): 13668-187
SILDENAFIL CITRATESILDENAFILNorthwind Health Company, LLCd9de0817-cac1-4ee5-e053-2a95a90a5fa72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091448
application number: ANDA091448

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN78c4551c-b922-43c9-9a5a-66377ea07bc224
312950sildenafil 50 MG Oral TabletSCD78c4551c-b922-43c9-9a5a-66377ea07bc224
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY78c4551c-b922-43c9-9a5a-66377ea07bc224
314229sildenafil citrate 100 MG Oral TabletPSNb48630b1-5208-4d00-b56f-21701f22375815
314228sildenafil citrate 25 MG Oral TabletPSNb48630b1-5208-4d00-b56f-21701f22375815
312950sildenafil citrate 50 MG Oral TabletPSNb48630b1-5208-4d00-b56f-21701f22375815
314229sildenafil 100 MG Oral TabletSCDb48630b1-5208-4d00-b56f-21701f22375815
314228sildenafil 25 MG Oral TabletSCDb48630b1-5208-4d00-b56f-21701f22375815
312950sildenafil 50 MG Oral TabletSCDb48630b1-5208-4d00-b56f-21701f22375815
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYb48630b1-5208-4d00-b56f-21701f22375815
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYb48630b1-5208-4d00-b56f-21701f22375815
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYb48630b1-5208-4d00-b56f-21701f22375815
312950sildenafil citrate 50 MG Oral TabletPSNa05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d61
312950sildenafil citrate 50 MG Oral TabletPSN52614168-3a9e-335d-e063-6394a90ac27f1
312950sildenafil 50 MG Oral TabletSCDa05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d61
312950sildenafil 50 MG Oral TabletSCD52614168-3a9e-335d-e063-6394a90ac27f1
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYa05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d61
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY52614168-3a9e-335d-e063-6394a90ac27f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-187-0113668018701100 TABLET, FILM COATED in 1 BOTTLE (13668-187-01) 2018-06-110000-00-00NoNoCurrent
13668-187-0513668018705500 TABLET, FILM COATED in 1 BOTTLE (13668-187-05) 2018-06-110000-00-00NoNoCurrent
13668-187-10136680187101000 TABLET, FILM COATED in 1 BOTTLE (13668-187-10) 2024-12-06NoNoCurrent
13668-187-18136680187181800 TABLET, FILM COATED in 1 BOTTLE (13668-187-18) 2018-06-110000-00-00NoNoCurrent
13668-187-301366801873030 TABLET, FILM COATED in 1 BOTTLE (13668-187-30) 2018-06-110000-00-00NoNoCurrent
13668-187-7413668018774100 BLISTER PACK in 1 CARTON (13668-187-74) > 10 TABLET, FILM COATED in 1 BLISTER PACK (13668-187-71) 100 blister pack2018-06-110000-00-00NoNoCurrent