Spironolactone

Product NDC
0228-2672
11-digit product format
002282672
Labeler code
0228
Product ID
0228-2672_c2c9d105-84e7-4a04-807f-d236959c0742
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA040353
Marketing category
ANDA
Marketing start
2007-01-03
Marketing end
2020-09-30
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0228-2672DDiscontinued by firm2026-08-11
excluded packagepackage0228-26720228-2672-11DDiscontinued by firm2026-08-11
excluded packagepackage0228-26720228-2672-50DDiscontinued by firm2026-08-11

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 packagepackage0228-2672-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0228-2672-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0228-2672-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0228-2672-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0228-2672-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0228-2672-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0228-2672-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0228-2672-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0228-2672-11cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0228-2672-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0228-2672-11cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0228-2672-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0228-2672-11302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0228-2672-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0228-2672-11ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0228-2672-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0228-2672-110efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0228-2672-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0228-2672-11ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0228-2672-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0228-2672-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0228-2672-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0228-2672-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0228-2672-50557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040353-001SPIRONOLACTONE50MGTABLET / 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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040353-002SPIRONOLACTONE100MGTABLET / ORAL1999-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040353-003SPIRONOLACTONE25MGTABLET / ORAL2006-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040353-001SPIRONOLACTONE50MGTABLET / ORAL1999-07-298072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2672-11EA - Each0228-2672d985b389-f4ec-4b5f-83c6-dbdb4addb78512012-07-24
0228-2672-50EA - Each0228-26723cf7ce43-8ae9-4a0e-baf3-6beb3665432112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQSPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]8
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN617aef1f-3f2c-4d33-8baf-40995b8f6a243
313096spironolactone 25 MG Oral TabletPSN617aef1f-3f2c-4d33-8baf-40995b8f6a243
198223spironolactone 50 MG Oral TabletPSN617aef1f-3f2c-4d33-8baf-40995b8f6a243
198222spironolactone 100 MG Oral TabletSCD617aef1f-3f2c-4d33-8baf-40995b8f6a243
313096spironolactone 25 MG Oral TabletSCD617aef1f-3f2c-4d33-8baf-40995b8f6a243
198223spironolactone 50 MG Oral TabletSCD617aef1f-3f2c-4d33-8baf-40995b8f6a243