Dexamethasone

Product NDC: 81279-117
Requested package NDC: 81279-117-88
11-digit product format: 812790117
Labeler code: 81279
Product ID: 81279-117_4fcc51f0-654d-a3a8-e063-6394a90aac9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Pangea Pharmaceuticals, LLC
Application: ANDA088149
Marketing category: ANDA
Marketing start: 2026-05-01
Substance: DEXAMETHASONE
Active strength: .25 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A088149-001	DEXAMETHASONE	DEXAMETHASONE	0.25MG	TABLET / ORAL			1983-04-28

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088149-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	1983-04-28	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Dexamethasone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	.25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197576	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
37607468-0331-44c0-9bb4-5c614c7b69d4	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
81279-117-60	Dexamethasone	60 in 1 BOTTLE	TABLET	60		1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Pangea Pharmaceuticals, LLC	a41e6e26-9ebb-4b06-866e-a24af21c644c	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088149 application number: ANDA088149 ndc (package): 81279-117-88 ndc (product): 81279-117 ndc11 (package): 81279011788
Dexamethasone	DEXAMETHASONE	Pangea Pharmaceuticals, LLC	37607468-0331-44c0-9bb4-5c614c7b69d4	2026-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088149 application number: ANDA088149 ndc (product): 81279-117

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
197576	dexAMETHasone 0.25 MG Oral Tablet	PSN	37607468-0331-44c0-9bb4-5c614c7b69d4	1
197576	dexamethasone 0.25 MG Oral Tablet	SCD	37607468-0331-44c0-9bb4-5c614c7b69d4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81279-117-88	81279011788	60 TABLET in 1 BOTTLE (81279-117-88)	60 tablet	2026-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP (0.25 mg)	Pangea Pharmaceuticals, LLC	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	1
DEXLYT TM (dexamethasone) tablets, USP (0.25 mg) Rx only	Pangea Pharmaceuticals, LLC	2026-04-19	HUMAN PRESCRIPTION DRUG LABEL	1