Dexamethasone

Product NDC: 85766-246
Requested package NDC: 85766-246-60
11-digit product format: 857660246
Labeler code: 85766
Product ID: 85766-246_56c7d5fc-9bba-2b33-e063-6394a90a4c1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA217001
Marketing category: ANDA
Marketing start: 2023-08-01
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217001-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2023-04-19
A217001-002	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB		2023-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217001-001	AB
A217001-002	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 · 48 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	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2023-04-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2023-04-19	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A217001-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217001-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217001-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217001-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217001-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217001-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217001-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217001-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217001-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217001-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217001-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217001-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217001-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217001-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217001-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217001-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217001-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217001-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217001-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217001-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217001-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217001-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217001-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217001-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217001-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217001-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217001-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217001-002	AB	1	`a72a2bbeb626…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197582	Internal RxNorm lookup
197583	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
a37486b9-4323-41fc-ac7e-869d95dc9568	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Sportpharm LLC	a37486b9-4323-41fc-ac7e-869d95dc9568	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001 ndc (package): 85766-246-60 ndc (product): 85766-246 ndc11 (package): 85766024660
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	429d0d32-a1ff-481b-b4e9-c0b17b3610a1	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Advanced Rx of Tennessee, LLC	348f5a56-978d-4272-e063-6294a90afdb6	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	3166db4f-66a5-496a-a194-3cc01b7347d3	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	b883860c-27ba-4bac-8ae3-4cf4d82d5071	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e652b041-2a0b-4bcd-a420-5d026302edbb	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001

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
85766-246-60	85766024660	60 TABLET in 1 BOTTLE (85766-246-60)	60 tablet	2026-07-17	No	No	Current