Sildenafil

Product NDC
70518-2128
Requested package NDC
70518-2128-2
11-digit product format
705182128
Labeler code
70518
Product ID
70518-2128_c624e283-b904-11f3-e053-2995a90ac629
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2019-06-04
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-212870518-2128-2DDiscontinued by firm2026-08-17

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
A202659-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11
A202659-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11
A202659-003SILDENAFIL 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
A202659-001AB
A202659-002AB
A202659-003AB

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 06:07:402026-07A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2018-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202659-001SILDENAFIL 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 06:07:402026-07A202659-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202659-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202659-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202659-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202659-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202659-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202659-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202659-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202659-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202659-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202659-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202659-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202659-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202659-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202659-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202659-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202659-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202659-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-2128-02023-03-07These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
70518-2128-12023-03-07These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
70518-2128-22023-03-07These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
70518-2128-32023-03-07These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
70518-2128-02023-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
70518-2128-12023-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
70518-2128-22023-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
70518-2128-32023-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2128SILDENAFIL TABLET, FILM COATED [REMEDYREPACK INC.]9Legacy NDC20250308_6a104328-3208-4157-be60-8fdc907d3825.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILREMEDYREPACK INC.99bc66a4-05d1-4372-a25a-1153d7af580e2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.e1af7b6a-378e-4337-858f-85a926eec1022026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.4e3034af-bee5-4df4-8beb-fbd2b510ad732026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILBryant Ranch Prepacke22902bd-e5a8-4df6-ae77-8a0a1484cc502026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILCamber Pharmaceuticals, Inc.dc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79982026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILCamber Pharmaceuticals, Inc.96ab1605-e171-4e86-b357-2d9378f7a05a2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNorthwind Health Company, LLCf3089ee6-190d-4749-e053-2a95a90a15d82026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILPreferred Pharmaceuticals, Inc.174ef537-e3e6-42bd-a478-47b930ddc7612025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SILDENAFILSILDENAFILDIRECT RXa84a418a-155c-7be7-e053-2995a90a81582025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILBryant Ranch Prepackf66ce83b-bad6-4180-a8c4-8475a8ec50b72024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.78101030-ef1d-44b9-e053-2991aa0a158d2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.7925711e-2e89-fd93-e053-2991aa0a507f2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.7d68a3d3-590b-0bd9-e053-2a91aa0ae8cd2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILA-S Medication Solutionseaeab74e-38cc-4621-9ce8-8a5d74a29a9e2023-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILA-S Medication Solutions997197bf-7706-4e12-97df-b0a9ea6d3a102023-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILA-S Medication Solutions3145ceda-8c1e-4601-8a9d-5fc4978226d62023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILXLCARE Pharmaceuticals INC.ae732301-384f-43ae-80d1-5e3784fe1dca2023-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILProficient Rx LP0aced3eb-cb0b-4135-905c-b274505aa7402022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659
SildenafilSILDENAFILProficient Rx LP5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202659
application number: ANDA202659

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2128-27051821280230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2128-2) 2019-06-140000-00-00NoNoCurrent