Sildenafil

Product NDC
0378-1659
11-digit product format
003781659
Labeler code
0378
Product ID
0378-1659_1d0e6262-2e9e-43ca-8f44-5f7e202a662c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201171
Marketing category
ANDA
Marketing start
2019-04-04
Marketing end
0000-00-00
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-1659DDiscontinued by firm2026-08-17
excluded packagepackage0378-16590378-1659-93DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0378-1659DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-16590378-1659-93DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A201171-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORAL2019-03-25
A201171-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORAL2019-03-25
A201171-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORAL2019-03-25

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 06:07:402026-07A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORAL2019-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORAL2019-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORAL2019-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORAL2019-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORAL2019-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORAL2019-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORAL2019-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORAL2019-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORAL2019-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201171-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201171-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201171-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-251e350fbaab3a…

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
2025-08-23 18:47 UTC2025-08A201171-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201171-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201171-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201171-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201171-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201171-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201171-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201171-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201171-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201171-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201171-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201171-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201171-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201171-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201171-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201171-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201171-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201171-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201171-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201171-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201171-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201171-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201171-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201171-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201171-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201171-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201171-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201171-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201171-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201171-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201171-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201171-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201171-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201171-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201171-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201171-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201171-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201171-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201171-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201171-001AB15d02ea3f76ae…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1659-93EA - Each0378-165912638b08-16c1-4952-851f-04232794277912019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1659SILDENAFIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4Legacy NDC20250215_cad6e3ac-84e5-4dae-9c26-8f6078f0da0c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1659-930037816599330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1659-93) 2019-04-040000-00-00NoNoCurrent