SILDENAFIL

Product NDC
70748-132
11-digit product format
707480132
Labeler code
70748
Product ID
70748-132_17c537d9-b2e6-4d71-a481-c7c7cafdb3a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA212051
Marketing category
ANDA
Marketing start
2019-09-27
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70748-132DDiscontinued by firm2026-10-05
excluded packagepackage70748-13270748-132-01DDiscontinued by firm2026-10-05
excluded packagepackage70748-13270748-132-06DDiscontinued by firm2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70748-132-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70748-132-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70748-132-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70748-132-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70748-132-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70748-132-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70748-132-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70748-132-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70748-132-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70748-132-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70748-132-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70748-132-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70748-132-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70748-132-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70748-132-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70748-132-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70748-132-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70748-132-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70748-132-06ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70748-132-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70748-132-06367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70748-132-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70748-132-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70748-132-01557ba5c1ecfa…9c80585c8c6e…

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
A212051-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22
A212051-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-22
A212051-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212051-001AB
A212051-002AB
A212051-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-2284e616aacf4f…
2026-09-14 22:38:342026-08A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-2284e616aacf4f…
2026-09-14 22:38:342026-08A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-2284e616aacf4f…
2026-08-18 06:07:402026-07A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212051-002SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2019-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212051-003SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2019-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212051-001SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2019-03-22301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212051-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212051-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A212051-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A212051-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212051-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212051-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212051-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212051-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212051-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212051-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212051-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212051-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212051-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212051-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212051-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212051-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212051-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212051-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212051-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212051-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212051-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212051-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212051-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212051-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212051-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212051-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212051-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212051-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212051-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212051-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212051-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212051-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212051-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212051-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212051-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212051-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212051-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212051-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212051-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212051-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-132-01EA - Each70748-1324e958e42-6d76-43ee-84ea-c2d8f88bd8d112019-10-07
70748-132-06EA - Each70748-132deb2a251-e5e1-4244-8bd2-40031e6bb8d712019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70748-132-0170748013201100 TABLET, FILM COATED in 1 BOTTLE (70748-132-01) 2019-09-270000-00-00NoNoCurrent
70748-132-067074801320630 TABLET, FILM COATED in 1 BOTTLE (70748-132-06) 2019-09-270000-00-00NoNoCurrent