Dexamethasone

Product NDC: 68788-7267
Requested package NDC: 68788-7267-2
11-digit product format: 687887267
Labeler code: 68788
Product ID: 68788-7267_51df9b81-1cd9-45f3-a21f-ef512c96446b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA084613
Marketing category: ANDA
Marketing start: 2018-09-25
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

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7267	68788-7267-2	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

Additional Listing Data#

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

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
955db121-79f4-47eb-8c10-01b2d8b411e4	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
68788-7267-0	Dexamethasone	100 in 1 BOTTLE, PLASTIC	TABLET	100	7
68788-7267-1	Dexamethasone	12 in 1 BOTTLE, PLASTIC	TABLET	12	7
68788-7267-2	Dexamethasone	21 in 1 BOTTLE, PLASTIC	TABLET	21	7
68788-7267-3	Dexamethasone	30 in 1 BOTTLE, PLASTIC	TABLET	30	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7267-0	EA - Each	68788-7267	94402c56-9cdd-41c6-b78a-260b1bbdf3f1	1	2018-11-06
68788-7267-1	EA - Each	68788-7267	88f14540-5f63-4f67-bb22-69d11849e01f	1	2018-11-06
68788-7267-2	EA - Each	68788-7267	9d2966cf-00de-4b05-87bd-9bc42eab2adc	1	2018-11-06
68788-7267-3	EA - Each	68788-7267	cd28014e-e6af-4dce-b629-70bc34b42c68	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7267	DEXAMETHASONE TABLET [PREFERRED PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 4 package rows	20250115_955db121-79f4-47eb-8c10-01b2d8b411e4.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 · 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
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 ndc (package): 68788-7267-2 ndc (product): 68788-7267 ndc11 (package): 68788726702
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

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	955db121-79f4-47eb-8c10-01b2d8b411e4	7
343033	dexamethasone 0.75 MG Oral Tablet	SCD	955db121-79f4-47eb-8c10-01b2d8b411e4	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7267-2	68788726702	21 TABLET in 1 BOTTLE, PLASTIC (68788-7267-2)	21 tablet	2018-09-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP Dexamethasone Oral Solution, USP and Dexamethasone Oral Solution, USP Intensol ™ (Concentrate)	Preferred Pharmaceuticals Inc.	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	7