SPIRONOLACTONE

Product NDC
70518-3118
Requested package NDC
70518-3118-0
11-digit product format
705183118
Labeler code
70518
Product ID
70518-3118_c4beb0fa-34b3-9469-e053-2995a90ad650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA089424
Marketing category
ANDA
Marketing start
2021-06-10
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-311870518-3118-0DDiscontinued 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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
A089424-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB1986-07-23
A089424-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB1999-08-11
A089424-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB1999-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089424-001AB
A089424-002AB
A089424-003AB

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 22:38:342026-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2384e616aacf4f…
2026-09-14 22:38:342026-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23301d65b070ca…

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 22:38:342026-08A089424-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A089424-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A089424-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A089424-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089424-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089424-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089424-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3118SPIRONOLACTONE TABLET [REMEDYREPACK INC.]5Legacy NDC20240926_093f2eb9-7c3b-4960-98cc-30d3d90aa094.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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3b60de71-2afa-4922-ba3e-0664c2ae29a02026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd6138536-cdc1-4459-84ff-9dedc0de11052026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcaf41e17-0461-4667-9eab-62853b9451312026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepacka6e0bf0e-42d3-41e4-854b-811df3bbaaa92026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1fe93db1-0012-4ff6-a4e6-04e2d7e9f6382026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1b29888c-09f9-4cd5-9b4c-920bd159a7272026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb98b7780-e310-493a-83bd-bb3d93cf8dde2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack753bbc6f-2e50-49c1-b5bf-18f8411a1e8e2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack0cc23419-e6d5-4036-8011-dc1d2455e0cb2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.7c59e03a-b058-4f6e-b104-0836d9b563922026-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEPreferred Pharmaceuticals Inc.3486d831-06b6-4e8f-bd6f-52f7759988f52026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONESun Pharmaceutical Industries, Inc.c23b6b9b-aec3-48a8-a518-76e4097f64792026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbe4aa233-1555-4972-858e-46343a7105582026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack11d06acd-1351-4afd-a16a-f035758e2a272026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackca194a2a-ed16-40f6-a78c-45c5f33921702026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackebc4efec-7895-4298-8e75-360bb7992f8d2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack813d199a-9004-4102-8ade-cf877caedafb2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbb1423e8-1517-44c5-98e0-99be24ce269b2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack2d0655d7-fda6-40c6-907c-acaba0e199872026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1c31c953-05ce-475a-b93f-80aeb12bde952026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3118-070518311800100 POUCH in 1 BOX (70518-3118-0) > 1 TABLET in 1 POUCH (70518-3118-1) 100 pouch2021-06-100000-00-00NoNoCurrent