spironolactone

Product NDC
67296-1692
11-digit product format
672961692
Labeler code
67296
Product ID
67296-1692_d61f8515-4a38-ce54-e053-2995a90a6082
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA205936
Marketing category
ANDA
Marketing start
2018-08-15
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct67296-1692IInactivated by FDA2026-08-11
excluded packagepackage67296-169267296-1692-3IInactivated by FDA2026-08-11

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 · 30 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 packagepackage67296-1692-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1692-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1692-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1692-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1692-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1692-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1692-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1692-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1692-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1692-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1692-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1692-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1692-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1692-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1692-31332a3947898…d4bfe170f9cd…

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
A205936-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB2018-07-18
A205936-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB2018-07-18
A205936-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB2018-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205936-001AB
A205936-002AB
A205936-003AB

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 · 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 UTC2026-02A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-002SPIRONOLACTONE50MGTABLET / ORALAB2018-07-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-003SPIRONOLACTONE100MGTABLET / ORALAB2018-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205936-001SPIRONOLACTONE25MGTABLET / ORALAB2018-07-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205936-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205936-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205936-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205936-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205936-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205936-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205936-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205936-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205936-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205936-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205936-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205936-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205936-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205936-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205936-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205936-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205936-001AB18072bd15b7f6…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1692-32024-01-30C16284748780-11030e365-511f-111a-e063-dadaa90a10e2SPIRONOLACTONE 25mg TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1692-3spironolactone30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1692SPIRONOLACTONE TABLET [REDPHARM DRUG, INC.]6Legacy NDC, 1 package rows20220123_b34d5a28-2a1d-e75b-e053-2a95a90a99f4.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.8b76a904-6c99-485a-a05f-13a36c5f720c2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONECardinal Health 107, LLC96db5dee-7c01-4f96-8b1e-1fcd2103d0fe2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONENorthwind Health Company, LLCf988aa11-60ed-411e-e053-6294a90a522a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONENorthwind Health Company, LLCf32e8109-73e1-a249-e053-2995a90a3fae2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONENorthwind Health Company, LLCf76b37a6-bcd4-2c8a-e053-6394a90aceea2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.eb27a2d2-1d28-4780-8e69-5fe613a0335e2025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONEMajor Pharmaceuticals0c45d793-6f2f-4622-b5ed-6875acfbc02b2025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONEZydus Lifesciences Limited963af399-feb7-49d2-a59c-c19edad9c6822025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONEZydus Pharmaceuticals (USA) Inc.99bbc053-0e41-4b4d-979a-db610908f2de2025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.39d82d50-0b77-4ef5-96b8-c1e05044a82c2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936
SpironolactoneSPIRONOLACTONEAmerican Health Packagingbd5ec154-b092-4c4d-8e72-ca2a2ef71a6d2024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205936
application number: ANDA205936

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNb34d5a28-2a1d-e75b-e053-2a95a90a99f46
313096spironolactone 25 MG Oral TabletSCDb34d5a28-2a1d-e75b-e053-2a95a90a99f46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1692-36729616920330 TABLET in 1 BOTTLE (67296-1692-3) 30 tablet2018-08-150000-00-00NoNoCurrent