Dexamethasone

Product NDC: 42291-155
11-digit product format: 422910155
Labeler code: 42291
Product ID: 42291-155_e78cbc6b-e80f-50e7-e053-2995a90a0a97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA088481
Marketing category: ANDA
Marketing start: 2022-08-31
Marketing end: 0000-00-00
Substance: DEXAMETHASONE
Active strength: 4 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-155		D	Discontinued by firm		2026-08-11
excluded package	package	42291-155	42291-155-01	D	Discontinued by firm		2026-08-11

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-155-01	EA - Each	42291-155	f60b75e8-9935-452f-94a4-59af24bb91a5	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-155	DEXAMETHASONE TABLET [AVKARE]	2	Legacy NDC	20240110_e78cbc6b-e80e-50e7-e053-2995a90a0a97.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-155-01	42291015501	100 TABLET in 1 BOTTLE (42291-155-01)	100 tablet	2022-08-31	0000-00-00	No	No	Current