FDA.reportPublic FDA data

spironolactone

Product NDC
31722-691
11-digit product format
317220691
Labeler code
31722
Product ID
31722-691_3241a29b-82b9-fd3a-e063-6294a90aa46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218085
Marketing category
ANDA
Marketing start
2025-02-21
Substance
SPIRONOLACTONE
Active strength
25 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218085-001SPIRONOLACTONESPIRONOLACTONE25MG/5MLSUSPENSION / ORALAB2025-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218085-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218085-001SPIRONOLACTONE25MG/5MLSUSPENSION / ORALAB2025-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218085-001SPIRONOLACTONE25MG/5MLSUSPENSION / ORALAB2025-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218085-001SPIRONOLACTONE25MG/5MLSUSPENSION / ORALAB2025-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218085-001SPIRONOLACTONE25MG/5MLSUSPENSION / ORALAB2025-02-21fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218085-001SPIRONOLACTONE25MG/5MLSUSPENSION / ORALAB2025-02-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218085-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218085-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218085-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218085-001AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218085-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE25 mg/5mL

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
104232Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ac2926a-949a-4383-b0b0-92c0822dfcdaAvailable 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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-691-11spironolactone118 mL in 1 BOTTLESUSPENSION1181
31722-691-47spironolactone473 mL in 1 BOTTLESUSPENSION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-691-11ML - Milliliter31722-691407709a8-6552-467b-a7f4-5da9edc93b8912025-09-12
31722-691-47ML - Milliliter31722-6917244f342-fc40-42d8-8bda-f81a209f24a412025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-691SPIRONOLACTONE (SPIRONOLACTONE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250410_4ac2926a-949a-4383-b0b0-92c0822dfcda.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
spironolactoneSPIRONOLACTONECamber Pharmaceuticals, Inc.4ac2926a-949a-4383-b0b0-92c0822dfcda2025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218085
application number: ANDA218085
ndc (product): 31722-691

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104232spironolactone 25 MG in 5 mL Oral SuspensionPSN4ac2926a-949a-4383-b0b0-92c0822dfcda1
104232spironolactone 5 MG/ML Oral SuspensionSCD4ac2926a-949a-4383-b0b0-92c0822dfcda1
104232spironolactone 25 MG per 5 ML Oral SuspensionSY4ac2926a-949a-4383-b0b0-92c0822dfcda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-691-1131722069111118 mL in 1 BOTTLE (31722-691-11) 118 ml2025-02-21NoNoCurrent
31722-691-4731722069147473 mL in 1 BOTTLE (31722-691-47) 473 ml2025-02-21NoNoCurrent