Dexamethasone

Product NDC: 49884-085
11-digit product format: 498840085
Labeler code: 49884
Product ID: 49884-085_7316c32b-7c02-47d8-a637-6c60c334f916
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical Inc.
Application: ANDA088160
Marketing category: ANDA
Marketing start: 1983-04-28
Marketing end: 2019-08-31
Substance: DEXAMETHASONE
Active strength: 1 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49884-085		D	Discontinued by firm		2026-10-05
excluded package	package	49884-085	49884-085-01	D	Discontinued by firm		2026-10-05

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 · 24 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	49884-085-01	`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	49884-085-01	`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	49884-085-01	`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	49884-085-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-085-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-085-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-085-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-085-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-085-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-085-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-085-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-085-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-085-01	EA - Each	49884-085	be478455-840b-48c9-a37a-09f047fae7bd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DEXAMETHASONE TABLET [PAR PHARMACEUTICAL INC.]	4
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DEXAMETHASONE TABLET [A-S MEDICATION SOLUTIONS LLC]	1

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	2dc5ea8d-82bf-40e1-b1cc-bee6bef2b62a	12
197582	dexAMETHasone 4 MG Oral Tablet	PSN	2dc5ea8d-82bf-40e1-b1cc-bee6bef2b62a	12
343033	dexamethasone 0.75 MG Oral Tablet	SCD	2dc5ea8d-82bf-40e1-b1cc-bee6bef2b62a	12
197582	dexamethasone 4 MG Oral Tablet	SCD	2dc5ea8d-82bf-40e1-b1cc-bee6bef2b62a	12

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone - Bryant Ranch Prepack	Bryant Ranch Prepack	2021-04-27	HUMAN PRESCRIPTION DRUG LABEL	6
Dexamethasone - Par Pharmaceutical Inc. \| Par Pharmaceutical, Inc.	Par Pharmaceutical Inc. \| Par Pharmaceutical, Inc.	2019-11-20	HUMAN PRESCRIPTION DRUG LABEL	7
Dexamethasone - A-S Medication Solutions	A-S Medication Solutions	2019-03-25	HUMAN PRESCRIPTION DRUG LABEL	12