Dexamethasone

Product NDC: 71335-3054
Requested package NDC: 71335-3054-8
11-digit product format: 713353054
Labeler code: 71335
Product ID: 71335-3054_015805cd-1e17-4e86-9a37-668597065f48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA216282
Marketing category: ANDA
Marketing start: 2024-04-15
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
e830be9d-0a8c-4712-93c6-284c208d6f0d	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
71335-3054-0	Dexamethasone	4 in 1 BOTTLE	TABLET	4	1
71335-3054-1	Dexamethasone	30 in 1 BOTTLE	TABLET	30	1
71335-3054-2	Dexamethasone	6 in 1 BOTTLE	TABLET	6	1
71335-3054-3	Dexamethasone	3 in 1 BOTTLE	TABLET	3	1
71335-3054-4	Dexamethasone	15 in 1 BOTTLE	TABLET	15	1
71335-3054-5	Dexamethasone	40 in 1 BOTTLE	TABLET	40	1
71335-3054-6	Dexamethasone	60 in 1 BOTTLE	TABLET	60	1
71335-3054-7	Dexamethasone	28 in 1 BOTTLE	TABLET	28	1
71335-3054-8	Dexamethasone	90 in 1 BOTTLE	TABLET	90	1
71335-3054-9	Dexamethasone	10 in 1 BOTTLE	TABLET	10	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 · 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
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 ndc (package): 71335-3054-8 ndc (product): 71335-3054 ndc11 (package): 71335305408
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197582	dexAMETHasone 4 MG Oral Tablet	PSN	e830be9d-0a8c-4712-93c6-284c208d6f0d	1
197582	dexamethasone 4 MG Oral Tablet	SCD	e830be9d-0a8c-4712-93c6-284c208d6f0d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3054-8	71335305408	90 TABLET in 1 BOTTLE (71335-3054-8)	90 tablet	2026-02-05	No	No	Current