Dexamethasone

Product NDC: 68788-7142
Requested package NDC: 68788-7142-6
11-digit product format: 687887142
Labeler code: 68788
Product ID: 68788-7142_516b5c33-de8c-47a1-ac2d-0396fe9a9410
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA084612
Marketing category: ANDA
Marketing start: 2018-04-19
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7142	68788-7142-6	D	Discontinued by firm		2026-08-17

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084612-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-002	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-003	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-004	DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15
A084612-005	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
A084612-006	DEXAMETHASONE	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A084612-007	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A084612-001	AB
A084612-002	AB
A084612-003	AB
A084612-004	AB
A084612-005	AB
A084612-006	AB
A084612-007	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 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-004	DEXAMETHASONE	1MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-005	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-006	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	RLD, RS	1983-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084612-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5c6f7cd8ea54…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A084612-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084612-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084612-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084612-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084612-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084612-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084612-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084612-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084612-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084612-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084612-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084612-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084612-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084612-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084612-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084612-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084612-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084612-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084612-001	AB	1	`5c6f7cd8ea54…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7142-1	EA - Each	68788-7142	5509408b-567c-4fdf-a69e-4d3ce955a97a	1	2018-06-11
68788-7142-3	EA - Each	68788-7142	3441d0c4-74bc-451d-92a0-9e44aeb2d101	1	2018-06-11
68788-7142-5	EA - Each	68788-7142	4395994c-f201-4dd9-92d2-a8be1074feba	1	2018-06-11

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	f5c9b70b-b835-4f3b-9643-0aec50a0d3f2	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	89e1d458-7caa-430f-9c54-360889899a73	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Cardinal Health 107, LLC	bf8acfdb-8dc8-4a69-90b0-33c680c421d6	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Northwind Health Company, LLC	aa30086a-8551-413e-9cf2-6393093cfcfd	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Golden State Medical Supply, Inc.	a7455c92-41ce-4e87-e053-2995a90a610f	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	cc7140de-a205-f675-e053-2995a90ac22b	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	99296e80-3ca6-4430-9ef7-adca357c31b3	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Doc Rx	f1c30431-554b-4161-9d8c-5795c689e0bd	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	89e570c9-3e64-433b-9779-b94332f2b5ef	2020-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084612 application number: ANDA084612

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
68788-7142-6	68788714206	6 TABLET in 1 BOTTLE, PLASTIC (68788-7142-6)	6 tablet	2022-04-22	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.	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	6