Dexamethasone

Product NDC: 71335-3010
Requested package NDC: 71335-3010-3
11-digit product format: 713353010
Labeler code: 71335
Product ID: 71335-3010_320ac974-e60b-475f-afc7-9a52746e45c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA217695
Marketing category: ANDA
Marketing start: 2023-12-05
Substance: DEXAMETHASONE
Active strength: 1.5 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217695-001	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-08-23
A217695-002	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-08-23
A217695-003	DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET / ORAL	AB	2023-08-23
A217695-004	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2023-08-23
A217695-005	DEXAMETHASONE	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-08-23
A217695-006	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-08-23
A217695-007	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217695-001	AB
A217695-002	AB
A217695-003	AB
A217695-004	AB
A217695-005	AB
A217695-006	AB
A217695-007	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 4 · 154 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	A217695-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-003	DEXAMETHASONE	1MG	TABLET / ORAL	AB	2023-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-004	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2023-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-005	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-006	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217695-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-003	DEXAMETHASONE	1MG	TABLET / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-004	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-005	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-006	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217695-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-003	DEXAMETHASONE	1MG	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-004	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-005	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-006	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-003	DEXAMETHASONE	1MG	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-004	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-005	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-006	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217695-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-003	DEXAMETHASONE	1MG	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-004	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-005	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-006	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-007	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-001	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-002	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-003	DEXAMETHASONE	1MG	TABLET / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-004	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-005	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-08-23	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 154 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	A217695-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217695-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217695-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217695-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217695-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217695-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217695-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217695-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217695-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217695-005	AB	1	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217695-003	CGT	2024-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217695-003	CGT	2024-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217695-003	CGT	2024-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217695-003	CGT	2024-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217695-003	CGT	2024-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217695-003	CGT	2024-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217695-003	CGT	2024-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217695-003	CGT	2024-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217695-003	CGT	2024-04-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217695-003	CGT	2024-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217695-003	CGT	2024-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217695-003	CGT	2024-04-29	`ea1830bbd6c7…`

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	1.5 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
197580	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
b3217057-5945-452c-aa99-ab696fd8b5e7	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
71335-3010-1	Dexamethasone	35 in 1 BOTTLE	TABLET	35	1
71335-3010-2	Dexamethasone	21 in 1 BOTTLE	TABLET	21	1
71335-3010-3	Dexamethasone	51 in 1 BOTTLE	TABLET	51	1
71335-3010-4	Dexamethasone	90 in 1 BOTTLE	TABLET	90	1
71335-3010-5	Dexamethasone	120 in 1 BOTTLE	TABLET	120	1
71335-3010-6	Dexamethasone	100 in 1 BOTTLE	TABLET	100	1
71335-3010-7	Dexamethasone	55 in 1 BOTTLE	TABLET	55	1
71335-3010-8	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Sportpharm LLC	12d19271-867b-41ae-a6d2-7e8de3637011	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217695 application number: ANDA217695
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	b3217057-5945-452c-aa99-ab696fd8b5e7	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217695 application number: ANDA217695 ndc (package): 71335-3010-3 ndc (product): 71335-3010 ndc11 (package): 71335301003
Dexamethasone	DEXAMETHASONE	Apotex Corp.	bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217695 application number: ANDA217695
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	3f2fe98a-ab42-4bec-bf97-c090567f9ad6	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217695 application number: ANDA217695

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
197580	dexAMETHasone 1.5 MG Oral Tablet	PSN	b3217057-5945-452c-aa99-ab696fd8b5e7	1
197580	dexamethasone 1.5 MG Oral Tablet	SCD	b3217057-5945-452c-aa99-ab696fd8b5e7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3010-3	71335301003	51 TABLET in 1 BOTTLE (71335-3010-3)	51 tablet	2026-02-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets USP R x Only	Bryant Ranch Prepack	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	1