SPIRONOLACTONE

Product NDC
71610-970
11-digit product format
716100970
Labeler code
71610
Product ID
71610-970_462bf397-a6df-e7a9-e063-6294a90afb60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
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 · 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 UTC2026-02A089424-001SPIRONOLACTONE25MGTABLET / 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-238072bd15b7f6…

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 UTC2026-02A089424-001AB1011fe1cb6892…
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089424-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089424-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089424-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089424-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
SPIRONOLACTONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27O7W4T232Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313096Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45232668-6952-80a0-e063-6294a90a6e4bAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-970-30SPIRONOLACTONE30 in 1 BOTTLETABLET302
71610-970-45SPIRONOLACTONE45 in 1 BOTTLETABLET452
71610-970-60SPIRONOLACTONE90 in 1 BOTTLETABLET902
71610-970-80SPIRONOLACTONE180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-970-30EA - Each71610-9708852102d-0d30-4934-9ef5-62cd0bbbfbed12026-03-17
71610-970-45EA - Each71610-97060a74a3b-a85c-46ae-9904-caacf54b40bc12026-03-17
71610-970-60EA - Each71610-970059fda82-6736-4dcb-a097-8e5d1904816212026-03-17
71610-970-80EA - Each71610-970f97f228a-ff7e-4b47-8055-689dc1f6d2c712026-03-17

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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
SPIRONOLACTONESPIRONOLACTONESun Pharmaceutical Industries, Inc.c23b6b9b-aec3-48a8-a518-76e4097f64792026-06-03Warnings, 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
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack10a5c989-66e3-494d-bfd8-b2d6df3be4112026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack753bbc6f-2e50-49c1-b5bf-18f8411a1e8e2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcae68fd6-5161-4650-bcde-6db98cbe6c8b2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3791d79c-d960-4790-b689-ea32ddf7226a2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcbc817de-5ea8-4139-9c13-02bac8ff93c32026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack2efb4720-625f-6616-b6f0-8b13a17c9d7e2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd4cf1136-df3a-4fc2-9a21-9032949eca412026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEAphena Pharma Solutions - Tennessee, LLC45232668-6952-80a0-e063-6294a90a6e4b2025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
ndc (product): 71610-970
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.7c59e03a-b058-4f6e-b104-0836d9b563922025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1b29888c-09f9-4cd5-9b4c-920bd159a7272024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN45232668-6952-80a0-e063-6294a90a6e4b2
313096spironolactone 25 MG Oral TabletSCD45232668-6952-80a0-e063-6294a90a6e4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-970-307161009703030 TABLET in 1 BOTTLE (71610-970-30) 30 tablet2025-12-16NoNoCurrent
71610-970-457161009704545 TABLET in 1 BOTTLE (71610-970-45) 45 tablet2025-12-03NoNoCurrent
71610-970-607161009706090 TABLET in 1 BOTTLE (71610-970-60) 90 tablet2025-12-03NoNoCurrent
71610-970-8071610097080180 TABLET in 1 BOTTLE (71610-970-80) 180 tablet2025-12-03NoNoCurrent