Dexamethasone

Product NDC: 55289-903
Requested package NDC: 55289-903-12
11-digit product format: 552890903
Labeler code: 55289
Product ID: 55289-903_30ca3216-ba04-488f-e063-6394a90a0671
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA084613
Marketing category: ANDA
Marketing start: 1975-06-03
Substance: DEXAMETHASONE
Active strength: .75 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.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084613-001	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	RLD, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084613-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084613-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084613-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084613-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084613-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084613-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084613-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084613-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084613-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084613-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084613-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084613-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084613-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084613-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084613-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084613-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084613-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084613-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084613-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084613-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084613-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084613-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084613-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084613-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084613-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084613-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084613-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084613-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084613-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084613-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084613-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084613-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084613-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084613-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084613-001	BP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084613-001	BP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084613-001	BP	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	736861fa-1df8-4afd-ba4a-dd7d7bffd865	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084613 application number: ANDA084613 ndc (package): 55289-903-12 ndc (product): 55289-903 ndc11 (package): 55289090312
Dexamethasone	DEXAMETHASONE	Direct_Rx	e90cb7f5-5e99-fbf3-e053-2995a90a70aa	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084613 application number: ANDA084613
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	955db121-79f4-47eb-8c10-01b2d8b411e4	2025-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084613 application number: ANDA084613
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	a9fd2013-0797-4ec4-82c5-07d282522625	2020-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084613 application number: ANDA084613

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	.75 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
343033	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
736861fa-1df8-4afd-ba4a-dd7d7bffd865	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	SPL version
55289-903-10	Dexamethasone	10 in 1 BOTTLE, PLASTIC	TABLET	10	18
55289-903-12	Dexamethasone	12 in 1 BOTTLE, PLASTIC	TABLET	12	18
55289-903-20	Dexamethasone	20 in 1 BOTTLE, PLASTIC	TABLET	20	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-903-10	EA - Each	55289-903	b90683e3-823a-447c-a46f-c1894ee2118e	1	2012-07-24
55289-903-12	EA - Each	55289-903	fa11e3df-1081-4fe2-a9ae-1cfb9fee5450	1	2013-02-13
55289-903-20	EA - Each	55289-903	c384e445-76d4-40c8-8879-47b5fc0b94af	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-903	DEXAMETHASONE TABLET [PD-RX PHARMACEUTICALS, INC.]	18	Current NDC, Legacy NDC, 3 package rows	20250322_736861fa-1df8-4afd-ba4a-dd7d7bffd865.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	736861fa-1df8-4afd-ba4a-dd7d7bffd865	18
343033	dexamethasone 0.75 MG Oral Tablet	SCD	736861fa-1df8-4afd-ba4a-dd7d7bffd865	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-903-12	55289090312	12 TABLET in 1 BOTTLE, PLASTIC (55289-903-12)	12 tablet	2009-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	19