Fludrocortisone Acetate

Product NDC
68084-288
11-digit product format
680840288
Labeler code
68084
Product ID
68084-288_35818f71-8d18-1daa-e063-6394a90aeb9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040431
Marketing category
ANDA
Marketing start
2008-09-05
Substance
FLUDROCORTISONE ACETATE
Active strength
.1 mg/1
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
A040431-001FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040431-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040431-001FLUDROCORTISONE ACETATE0.1MGTABLET / ORALABRS2002-03-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040431-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040431-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040431-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040431-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040431-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040431-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040431-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040431-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040431-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040431-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040431-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040431-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040431-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040431-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040431-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040431-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040431-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040431-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040431-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040431-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040431-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040431-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040431-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040431-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040431-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040431-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040431-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040431-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040431-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040431-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040431-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040431-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040431-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040431-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040431-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040431-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040431-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040431-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040431-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040431-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDROCORTISONE ACETATE.1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V47IF0PVH4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313979Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
001e72ea-2c9e-468c-90cc-6c347234e2a9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fff94984-a082-0061-d8a9-f1ca884c7b96Product name320250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-288-01Fludrocortisone Acetate100 in 1 BOX, UNIT-DOSETABLET1009
68084-288-11Fludrocortisone Acetate1 in 1 BLISTER PACKTABLET19
68084-288-65Fludrocortisone Acetate50 in 1 CARTONTABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-288-01EA - Each68084-288bcf4f7e9-2d86-47f4-bada-0c04a62ce67812012-07-24
68084-288-11EA - Each68084-288e0acd8ce-5a06-4cb5-a5b7-2b15e73b17a612012-07-24
68084-288-65EA - Each68084-28841bcc2e3-8126-4759-81c0-03dd3d1b141812023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
FludrocortisoneACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [CARDINAL HEALTH]4
FLUDROCORTISONE ACETATEACTIVE INGREDIENTV47IF0PVH4FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
FludrocortisoneACTIVE MOIETYU0476M545BFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-288FLUDROCORTISONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 3 package rows20250523_001e72ea-2c9e-468c-90cc-6c347234e2a9.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fludrocortisone AcetateFLUDROCORTISONE ACETATECardinal Health 107, LLC89b5687a-6e21-47cd-9c05-d9c9f4f8cf492026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040431
application number: ANDA040431
Fludrocortisone AcetateFLUDROCORTISONE ACETATENCS HealthCare of KY, LLC dba Vangard Labs3c007f9a-4cd5-4e74-a633-d55dde1fe9032026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040431
application number: ANDA040431
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAvKAREb8ce5b7e-7aa2-45f8-e053-2995a90a6c652026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040431
application number: ANDA040431
FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAK2cd3965d-cab9-a97c-db61-7d03ced154f32026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040431
application number: ANDA040431
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLC4ed382df-f2d5-46a4-a68b-aba8077770932025-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040431
application number: ANDA040431
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmerican Health Packaging001e72ea-2c9e-468c-90cc-6c347234e2a92025-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040431
application number: ANDA040431
ndc (product): 68084-288
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals NY LLC51363453-6d33-4aee-8426-37ac0bf3cc102024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040431
application number: ANDA040431

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN89b5687a-6e21-47cd-9c05-d9c9f4f8cf4915
313979fludrocortisone acetate 0.1 MG Oral TabletSCD89b5687a-6e21-47cd-9c05-d9c9f4f8cf4915
313979fludrocortisone acetate 0.1 MG Oral TabletPSN001e72ea-2c9e-468c-90cc-6c347234e2a99
313979fludrocortisone acetate 0.1 MG Oral TabletSCD001e72ea-2c9e-468c-90cc-6c347234e2a99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-288-0168084028801100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-288-01) / 1 TABLET in 1 BLISTER PACK (68084-288-11) 100 blister pack2008-09-050000-00-00NoNoCurrent
68084-288-11680840288111 in 1 BLISTER PACKHistorical
68084-288-656808402886550 BLISTER PACK in 1 CARTON (68084-288-65) / 1 TABLET in 1 BLISTER PACK (68084-288-11) 50 blister pack2023-02-09NoNoCurrent