Dexamethasone

Product NDC: 52959-547
11-digit product format: 529590547
Labeler code: 52959
Product ID: 52959-547_766589d0-3080-0c29-e053-2991aa0a9d7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA088238
Marketing category: ANDA
Marketing start: 1983-04-28
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 15 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-547		I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-01	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-04	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-05	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-07	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-10	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-11	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-12	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-16	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-18	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-20	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-21	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-28	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-30	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-547	52959-547-50	I	Inactivated by FDA	2026-10-16

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 6 · 315 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-547-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-547-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-547-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-547-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-547-01	0392/0547 DEXAMETHASONE
52959-547-04	0392/0547 DEXAMETHASONE
52959-547-05	0392/0547 DEXAMETHASONE
52959-547-07	0392/0547 DEXAMETHASONE
52959-547-10	0392/0547 DEXAMETHASONE
52959-547-11	0392/0547 DEXAMETHASONE
52959-547-12	0392/0547 DEXAMETHASONE
52959-547-16	0392/0547 DEXAMETHASONE
52959-547-18	0392/0547 DEXAMETHASONE
52959-547-20	0392/0547 DEXAMETHASONE
52959-547-21	0392/0547 DEXAMETHASONE
52959-547-28	0392/0547 DEXAMETHASONE
52959-547-30	0392/0547 DEXAMETHASONE
52959-547-50	0392/0547 DEXAMETHASONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-547-01	Dexamethasone	1 in 1 BOTTLE, PLASTIC	TABLET	1	3
52959-547-04	Dexamethasone	4 in 1 BOTTLE, PLASTIC	TABLET	4	3
52959-547-05	Dexamethasone	5 in 1 BOTTLE, PLASTIC	TABLET	5	3
52959-547-07	Dexamethasone	7 in 1 BOTTLE, PLASTIC	TABLET	7	3
52959-547-10	Dexamethasone	10 in 1 BOTTLE, PLASTIC	TABLET	10	3
52959-547-11	Dexamethasone	11 in 1 BOTTLE, PLASTIC	TABLET	11	3
52959-547-12	Dexamethasone	12 in 1 BOTTLE, PLASTIC	TABLET	12	3
52959-547-16	Dexamethasone	16 in 1 BOTTLE, PLASTIC	TABLET	16	3
52959-547-18	Dexamethasone	18 in 1 BOTTLE, PLASTIC	TABLET	18	3
52959-547-20	Dexamethasone	20 in 1 BOTTLE, PLASTIC	TABLET	20	3
52959-547-21	Dexamethasone	21 in 1 BOTTLE, PLASTIC	TABLET	21	3
52959-547-28	Dexamethasone	28 in 1 BOTTLE, PLASTIC	TABLET	28	3
52959-547-30	Dexamethasone	30 in 1 BOTTLE, PLASTIC	TABLET	30	3
52959-547-50	Dexamethasone	50 in 1 BOTTLE, PLASTIC	TABLET	50	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-547-04	EA - Each	52959-547	159b6722-40ca-4339-90bf-364a839f4950	1	2012-07-24
52959-547-10	EA - Each	52959-547	3f09102e-dd37-461c-88f3-467b99df051d	1	2012-07-24
52959-547-11	EA - Each	52959-547	b1751bdf-3bc7-431f-b5ca-1304b34ebbef	1	2012-07-24
52959-547-12	EA - Each	52959-547	b7e3c366-2fd3-4d09-a03a-acbdfd9bc506	1	2012-07-24
52959-547-16	EA - Each	52959-547	078e9b66-439b-40d2-8d27-6b43f1f08f61	1	2012-07-24
52959-547-20	EA - Each	52959-547	b9850fac-1931-4b3c-a02b-dc681691af7f	1	2012-07-24
52959-547-30	EA - Each	52959-547	2a599849-92d5-4c51-b760-32461b5f46e0	1	2012-07-24
52959-547-50	EA - Each	52959-547	bd3be953-269e-4443-b066-9cdca497d5dd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	DEXAMETHASONE TABLET [H.J. HARKINS COMPANY, INC.]	2
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE TABLET [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-547	DEXAMETHASONE TABLET [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 14 package rows	20180922_ec27c135-8ffd-4487-a4fa-7c0514e843e6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
343033	dexAMETHasone 0.75 MG Oral Tablet	PSN	ec27c135-8ffd-4487-a4fa-7c0514e843e6	3
197582	dexAMETHasone 4 MG Oral Tablet	PSN	ec27c135-8ffd-4487-a4fa-7c0514e843e6	3
343033	dexamethasone 0.75 MG Oral Tablet	SCD	ec27c135-8ffd-4487-a4fa-7c0514e843e6	3
197582	dexamethasone 4 MG Oral Tablet	SCD	ec27c135-8ffd-4487-a4fa-7c0514e843e6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-547-01	52959054701	1 in 1 BOTTLE, PLASTIC	Historical
52959-547-04	52959054704	4 in 1 BOTTLE, PLASTIC	Historical
52959-547-05	52959054705	5 in 1 BOTTLE, PLASTIC	Historical
52959-547-07	52959054707	7 in 1 BOTTLE, PLASTIC	Historical
52959-547-10	52959054710	10 in 1 BOTTLE, PLASTIC	Historical
52959-547-11	52959054711	11 in 1 BOTTLE, PLASTIC	Historical
52959-547-12	52959054712	12 in 1 BOTTLE, PLASTIC	Historical
52959-547-16	52959054716	16 in 1 BOTTLE, PLASTIC	Historical
52959-547-18	52959054718	18 in 1 BOTTLE, PLASTIC	Historical
52959-547-20	52959054720	20 in 1 BOTTLE, PLASTIC	Historical
52959-547-21	52959054721	21 in 1 BOTTLE, PLASTIC	Historical
52959-547-28	52959054728	28 in 1 BOTTLE, PLASTIC	Historical
52959-547-30	52959054730	30 in 1 BOTTLE, PLASTIC	Historical
52959-547-50	52959054750	50 in 1 BOTTLE, PLASTIC	Historical