Sildenafil

Product NDC
13668-185
11-digit product format
136680185
Labeler code
13668
Product ID
13668-185_8b584f5d-8030-4f91-a129-8120f9e1b204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
Substance
SILDENAFIL CITRATE
Active strength
20 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091479-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091479-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063f01610625f2…
2019-09-15 20:21 UTC2019-09A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091479-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091479-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091479-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091479-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091479-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091479-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091479-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091479-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091479-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091479-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091479-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091479-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091479-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091479-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091479-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091479-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091479-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091479-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091479-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091479-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091479-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091479-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091479-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091479-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091479-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091479-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091479-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091479-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091479-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091479-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091479-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091479-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091479-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091479-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091479-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091479-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091479-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091479-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091479-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091479-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091479-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 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
577033Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bc081f2-399d-43fa-9e0f-9f8df0118e99Available 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
13668-185-05Sildenafil500 in 1 BOTTLETABLET, FILM COATED50020
13668-185-10Sildenafil1000 in 1 BOTTLETABLET, FILM COATED100020
13668-185-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED3020
13668-185-51Sildenafil5000 in 1 BOTTLETABLET, FILM COATED500020
13668-185-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-185-05EA - Each13668-1857547c695-4a00-4170-9aff-60944a8e745f12013-02-13
13668-185-90EA - Each13668-1857c13af64-f510-4f11-be6a-869bf10185c012013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-185SILDENAFIL TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]17Current NDC, Legacy NDC, 5 package rows20250209_1bc081f2-399d-43fa-9e0f-9f8df0118e99.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILBryant Ranch Prepack486dcfc4-f07a-4a78-86f0-f1c5ae448dc12026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFILSILDENAFILMajor Pharmaceuticalsa65b5fb3-ca3c-4226-9caa-42fb9a2f73732026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SildenafilSILDENAFILTorrent Pharmaceuticals Limited1bc081f2-399d-43fa-9e0f-9f8df0118e992026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
ndc (product): 13668-185
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.48c56418-0e45-083f-e063-6294a90a57b32026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFILSILDENAFILCardinal Health 107, LLCc5ac2265-393a-4fbe-b974-1dd0b9243ec82026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SildenafilSILDENAFILProficient Rx LP71140bd5-0a51-4c01-ad0d-193d08ea67dd2025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFIL CITRATESILDENAFIL CITRATEA-S Medication Solutions28a3376b-e50e-4789-9916-803ba29a15222024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
Sildenafil CitrateSILDENAFIL CITRATEAdvanced Rx Pharmacy of Tennessee, LLCf925abbe-4977-00b0-e053-6294a90a6e532024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479
SILDENAFIL CITRATESILDENAFIL CITRATEAsclemed USA, Inc.49a95b25-08b3-4cfe-a60b-c5132c280be22023-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091479
application number: ANDA091479

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN1bc081f2-399d-43fa-9e0f-9f8df0118e9920
577033sildenafil 20 MG Oral TabletSCD1bc081f2-399d-43fa-9e0f-9f8df0118e9920
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY1bc081f2-399d-43fa-9e0f-9f8df0118e9920
577033sildenafil citrate 20 MG Oral TabletPSNa65b5fb3-ca3c-4226-9caa-42fb9a2f73739
577033sildenafil 20 MG Oral TabletSCDa65b5fb3-ca3c-4226-9caa-42fb9a2f73739
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa65b5fb3-ca3c-4226-9caa-42fb9a2f73739
577033sildenafil citrate 20 MG Oral TabletPSN28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil 20 MG Oral TabletSCD28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil citrate 20 MG Oral TabletPSNf925abbe-4977-00b0-e053-6294a90a6e532
577033sildenafil citrate 20 MG Oral TabletPSNa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG Oral TabletSCDa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG Oral TabletSCDf925abbe-4977-00b0-e053-6294a90a6e532
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf925abbe-4977-00b0-e053-6294a90a6e532
577033sildenafil citrate 20 MG Oral TabletPSN49a95b25-08b3-4cfe-a60b-c5132c280be21
577033sildenafil citrate 20 MG Oral TabletPSN71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil citrate 20 MG Oral TabletPSN48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil citrate 20 MG Oral TabletPSN486dcfc4-f07a-4a78-86f0-f1c5ae448dc11
577033sildenafil 20 MG Oral TabletSCD48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil 20 MG Oral TabletSCD49a95b25-08b3-4cfe-a60b-c5132c280be21
577033sildenafil 20 MG Oral TabletSCD71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil 20 MG Oral TabletSCD486dcfc4-f07a-4a78-86f0-f1c5ae448dc11
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY49a95b25-08b3-4cfe-a60b-c5132c280be21
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY486dcfc4-f07a-4a78-86f0-f1c5ae448dc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-185-0513668018505500 TABLET, FILM COATED in 1 BOTTLE (13668-185-05) 2012-11-060000-00-00NoNoCurrent
13668-185-10136680185101000 TABLET, FILM COATED in 1 BOTTLE (13668-185-10) 2024-12-04NoNoCurrent
13668-185-301366801853030 TABLET, FILM COATED in 1 BOTTLE (13668-185-30) 2012-11-060000-00-00NoNoCurrent
13668-185-51136680185515000 TABLET, FILM COATED in 1 BOTTLE (13668-185-51) 2012-11-060000-00-00NoNoCurrent
13668-185-7413668018574100 TABLET in 1 CARTON (13668-185-74) 100 tablet2012-11-060000-00-00NoNoCurrent
13668-185-901366801859090 TABLET, FILM COATED in 1 BOTTLE (13668-185-90) 2012-11-060000-00-00NoNoCurrent