Dexamethasone

Product NDC: 68788-4113
11-digit product format: 687884113
Labeler code: 68788
Product ID: 68788-4113_79b65fd4-16a5-42e0-b041-61d7bda0a5ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc
Application: ANDA216282
Marketing category: ANDA
Marketing start: 2026-06-08
Substance: DEXAMETHASONE
Active strength: 4 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216282-001	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07
A216282-002	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07
A216282-003	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07
A216282-004	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07
A216282-005	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A216282-001	AB
A216282-002	AB
A216282-003	AB
A216282-004	AB
A216282-005	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 3 · 95 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
2026-09-14 22:38:34	2026-08	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2024-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2024-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-003	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2024-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2024-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-005	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2024-02-07	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 95 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216282-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216282-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216282-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216282-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216282-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216282-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216282-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216282-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216282-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216282-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216282-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216282-005	AB	1	`03ed91905a0d…`

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	4 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
197582	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
79b65fd4-16a5-42e0-b041-61d7bda0a5ff	Available on FDA.report

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc	79b65fd4-16a5-42e0-b041-61d7bda0a5ff	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216282 application number: ANDA216282 ndc (product): 68788-4113
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	8deaaaf7-3efd-4065-b29f-e5ef038030f8	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216282 application number: ANDA216282
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e830be9d-0a8c-4712-93c6-284c208d6f0d	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216282 application number: ANDA216282
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	64577454-d49e-4180-99e6-8461f74b0221	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216282 application number: ANDA216282
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	a5609df4-4933-4f85-a7b8-bc54a70a2bac	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216282 application number: ANDA216282
Dexamethasone	DEXAMETHASONE	Direct_rx	214dea63-d77a-922a-e063-6294a90a967e	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216282 application number: ANDA216282
Dexamethasone	DEXAMETHASONE	Viona Pharmaceuticals Inc	93bb34a7-c8ca-4dab-b2a0-cbe011e1090c	2024-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216282 application number: ANDA216282
Dexamethasone	DEXAMETHASONE	Zydus Lifesciences Limited	522a1a49-5540-4245-a15f-e3cdc0a97a5e	2024-03-30		Exact identifier application applno (ANDA): 216282 application number: ANDA216282

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	Sample	Exclude flag	Status
68788-4113-1	68788411301	12 TABLET in 1 BOTTLE (68788-4113-1)	12 tablet	2026-06-08	No	No	Current
68788-4113-3	68788411303	30 TABLET in 1 BOTTLE (68788-4113-3)	30 tablet	2026-06-08	No	No	Current
68788-4113-5	68788411305	15 TABLET in 1 BOTTLE (68788-4113-5)	15 tablet	2026-06-08	No	No	Current
68788-4113-6	68788411306	6 TABLET in 1 BOTTLE (68788-4113-6)	6 tablet	2026-06-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets, USP	Preferred Pharmaceuticals Inc	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	1