Dexamethasone

Product NDC: 47781-916
11-digit product format: 477810916
Labeler code: 47781
Product ID: 47781-916_f5d1d20f-dcb0-9ddf-b436-165cf014f5fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Alvogen Inc.
Application: ANDA088481
Marketing category: ANDA
Marketing start: 2021-06-28
Substance: DEXAMETHASONE
Active strength: 6 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A088481-001	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28
A088481-002	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28
A088481-003	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28
A088481-004	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A088481-001	AB
A088481-002	BP
A088481-003	BP
A088481-004	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 5 · 164 observed 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
2026-02-19 14:30 UTC	2026-02	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A088481-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-002	BP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-003	BP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-002	BP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-003	BP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088481-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-002	BP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-003	BP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-002	BP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-003	BP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-002	BP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-003	BP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-002	BP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-003	BP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-002	BP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-003	BP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-002	BP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-003	BP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-002	BP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-003	BP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088481-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-002	BP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-003	BP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dexamethasone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7S5I7G3JQL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197582	Internal RxNorm lookup
197583	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
9ab26af9-8196-e3d3-76a3-75227fd4e1c3	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47781-916-01	Dexamethasone	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-916-01	EA - Each	47781-916	d3489727-018c-411b-ab93-1c0f1fd894da	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47781-916	DEXAMETHASONE TABLET [ALVOGEN INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240613_9ab26af9-8196-e3d3-76a3-75227fd4e1c3.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
Dexamethasone	DEXAMETHASONE	Redpharm Drug, Inc.	115e1bfb-1697-d567-e063-6394a90a78e5	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	fa16db27-3c8c-eb22-e053-6394a90add59	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	36f104ba-80b4-4713-aa74-f80483b7bded	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481
Dexamethasone	DEXAMETHASONE	Alvogen Inc.	9ab26af9-8196-e3d3-76a3-75227fd4e1c3	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481 ndc (product): 47781-916
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	6f917c55-034a-40c5-9011-0e10e94d0eba	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481

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
197582	dexAMETHasone 4 MG Oral Tablet	PSN	9ab26af9-8196-e3d3-76a3-75227fd4e1c3	5
197583	dexAMETHasone 6 MG Oral Tablet	PSN	9ab26af9-8196-e3d3-76a3-75227fd4e1c3	5
197582	dexamethasone 4 MG Oral Tablet	SCD	9ab26af9-8196-e3d3-76a3-75227fd4e1c3	5
197583	dexamethasone 6 MG Oral Tablet	SCD	9ab26af9-8196-e3d3-76a3-75227fd4e1c3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-916-01	47781091601	100 TABLET in 1 BOTTLE (47781-916-01)	100 tablet	2021-08-30	0000-00-00	No	No	Current