Fludrocortisone Acetate

Product NDC: 0904-7317
11-digit product format: 009047317
Labeler code: 0904
Product ID: 0904-7317_b450e16e-26ca-424c-8f9f-3ed4ede6f0f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fludrocortisone Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA215279
Marketing category: ANDA
Marketing start: 2024-09-04
Substance: FLUDROCORTISONE ACETATE
Active strength: .1 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215279-001	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB		2022-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215279-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215279-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215279-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215279-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215279-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215279-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215279-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215279-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215279-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215279-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215279-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215279-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215279-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215279-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215279-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215279-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215279-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215279-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215279-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215279-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215279-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215279-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215279-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215279-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215279-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215279-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215279-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215279-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215279-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215279-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215279-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215279-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Fludrocortisone Acetate
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V47IF0PVH4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
933e28ef-05e8-419e-a786-21eab67f33a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fff94984-a082-0061-d8a9-f1ca884c7b96	Product name	3	20250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7317-06	Fludrocortisone Acetate	1 in 1 BLISTER PACK	TABLET	1	2
0904-7317-06	Fludrocortisone Acetate	50 in 1 CARTON	TABLET	50	2
0904-7317-61	Fludrocortisone Acetate	100 in 1 CARTON	TABLET	100	2
0904-7317-61	Fludrocortisone Acetate	1 in 1 BLISTER PACK	TABLET	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7317-06	EA - Each	0904-7317	3e109a2b-3d26-4973-80ec-b6b4756d33e0	1	2024-12-10
0904-7317-61	EA - Each	0904-7317	b786dae7-33aa-482c-856d-3713a028f050	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7317	FLUDROCORTISONE ACETATE TABLET [MAJOR PHARMACEUTICALS]	1	Current NDC, 4 package rows	20240906_933e28ef-05e8-419e-a786-21eab67f33a2.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Major Pharmaceuticals	933e28ef-05e8-419e-a786-21eab67f33a2	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279 ndc (product): 0904-7317
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Bryant Ranch Prepack	3d6f1a89-ea11-474d-aaca-64fea02a3beb	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NorthStar Rx LLC	04ad6ba3-6781-b5df-e063-6294a90a7e6e	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Novitium Pharma LLC	96dbbf53-962b-49a4-a60d-91ae0b9fb9ff	2022-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V47IF0PVH4	FLUDROCORTISONE ACETATE	514-36-3	FLUDROCORTISONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313979	fludrocortisone acetate 0.1 MG Oral Tablet	PSN	3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7	2
313979	fludrocortisone acetate 0.1 MG Oral Tablet	PSN	933e28ef-05e8-419e-a786-21eab67f33a2	2
313979	fludrocortisone acetate 0.1 MG Oral Tablet	SCD	3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7	2
313979	fludrocortisone acetate 0.1 MG Oral Tablet	SCD	933e28ef-05e8-419e-a786-21eab67f33a2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7317-06	00904731706	50 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACK	50 blister pack	2024-09-04	No	No	Current
0904-7317-61	00904731761	100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2024-09-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fludrocortisone Acetate Tablets, USP (0.1 mg) Rx only	Major Pharmaceuticals	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	3
Fludrocortisone Acetate Tablets, USP (0.1 mg) Rx only	Cardinal Health 107, LLC	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	2