FDA.reportPublic FDA data

Spironolactone

Product NDC
68788-9124
11-digit product format
687889124
Labeler code
68788
Product ID
68788-9124_260b560d-94c7-42f7-bedd-5f42972f2b12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA040353
Marketing category
ANDA
Marketing start
1994-03-25
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9124DDiscontinued by firm2026-08-17
excluded packagepackage68788-912468788-9124-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-912468788-9124-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-912468788-9124-9DDiscontinued 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 · 48 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 packagepackage68788-9124-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9124-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9124-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9124-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9124-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9124-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9124-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9124-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9124-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9124-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9124-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9124-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9124-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9124-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9124-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9124-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9124-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9124-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9124-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9124-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9124-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9124-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9124-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9124-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9124-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9124-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9124-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9124-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9124-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9124-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9124-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9124-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9124-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9124-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9124-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9124-9557ba5c1ecfa…9c80585c8c6e…

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
A040353-001SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORAL1999-07-29
A040353-002SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORAL1999-07-29
A040353-003SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORAL2006-03-15

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 06:07:402026-07A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-291e350fbaab3a…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2SPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [PREFERRED PHARMACEUTICALS, INC]1