Fludrocortisone Acetate

Product NDC: 0615-6562
11-digit product format: 006156562
Labeler code: 0615
Product ID: 0615-6562_8ee49c80-0201-4532-a8b7-918fbd031ff4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUDROCORTISONE ACETATE
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA040431
Marketing category: ANDA
Marketing start: 2002-03-18
Substance: FLUDROCORTISONE ACETATE
Active strength: .1 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-6562-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-6562-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040431-001	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040431-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040431-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	RS	2002-03-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040431-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040431-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040431-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040431-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040431-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040431-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040431-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040431-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040431-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040431-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040431-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040431-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040431-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040431-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040431-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040431-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040431-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040431-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040431-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040431-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040431-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040431-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040431-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040431-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040431-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040431-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040431-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040431-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040431-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040431-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040431-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040431-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040431-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040431-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040431-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040431-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040431-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040431-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040431-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040431-001	AB	1	`cb3db0bc1861…`

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
3c007f9a-4cd5-4e74-a633-d55dde1fe903	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-6562-39	2020-11-17	C162847	48780-1	9d75b9d0-b48b-f424-e053-dadaa90a57ce	Fludrocortisone Acetate Tablets, USP (0.1 mg)
0615-6562-39	2020-01-31	C162847	48780-1	9d75b9d0-b48b-f424-e053-dadaa90a57ce	Fludrocortisone Acetate Tablets, USP (0.1 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0615-6562-39	Fludrocortisone Acetate	30 in 1 BLISTER PACK	TABLET	30		19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUDROCORTISONE ACETATE	ACTIVE INGREDIENT	V47IF0PVH4	FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FLUDROCORTISONE	ACTIVE MOIETY	U0476M545B	FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-6562	FLUDROCORTISONE ACETATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	7	Current NDC, Legacy NDC, 1 package rows	20250108_3c007f9a-4cd5-4e74-a633-d55dde1fe903.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	89b5687a-6e21-47cd-9c05-d9c9f4f8cf49	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NCS HealthCare of KY, LLC dba Vangard Labs	3c007f9a-4cd5-4e74-a633-d55dde1fe903	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431 ndc (product): 0615-6562
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	AvKARE	b8ce5b7e-7aa2-45f8-e053-2995a90a6c65	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431
FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	2cd3965d-cab9-a97c-db61-7d03ced154f3	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	4ed382df-f2d5-46a4-a68b-aba807777093	2025-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	American Health Packaging	001e72ea-2c9e-468c-90cc-6c347234e2a9	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals NY LLC	51363453-6d33-4aee-8426-37ac0bf3cc10	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040431 application number: ANDA040431

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	3c007f9a-4cd5-4e74-a633-d55dde1fe903	19
313979	fludrocortisone acetate 0.1 MG Oral Tablet	SCD	3c007f9a-4cd5-4e74-a633-d55dde1fe903	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-6562-39	00615656239	30 TABLET in 1 BLISTER PACK (0615-6562-39)	30 tablet	2020-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fludrocortisone Acetate Tablets, USP (0.1 mg)	NCS HealthCare of KY, LLC dba Vangard Labs	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	19